Decisions26
Applicants15
Latest2026-09-30
FDA decided 26 premarket notifications (510(k)s) for immunology devices from 15 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.
| Decided | Applicant | Device | Where | Record |
|---|---|---|---|---|
| 2026-09-30 | Revvity, Inc. | Eonis SMA kit QUE | Waltham, Massachusetts | K262893 |
| 2026-09-04 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) DHB | GB | K260331 |
| 2026-08-21 | Immunodiagnostics Systems Limited | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La LLL | GB | K253817 |
| 2026-08-21 | Zeus Scientific | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM MOB | Branchburg, New Jersey | K261466 |
| 2026-08-19 | C2N Diagnostics, LLC | PrecivityAD2 Test SET | St. Louis, Missouri | K253240 |
| 2026-08-19 | Roche Diagnostics | Elecsys Phospho-Tau (217P) Plasma SET | Indianapolis, Indiana | K261686 |
| 2026-08-10 | Siemens Healthcare Diagnostics, Inc. | Atellica IM CA 19-9 II NIG | Tarrytown, New York | K253528 |
| 2026-08-07 | Cepheid | Xpert Hemorrhagic Fever QVR | Sunnyvale, California | K261362 |
| 2026-07-24 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut DHB | Garden Grove, California | K261027 |
| 2026-07-21 | Hycor Biomedical | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut DHB | Garden Grove, California | K260591 |
| 2026-06-25 | Phadia AB | EliA CTD 13 Screen LLL | SE | K253367 |
| 2026-06-18 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg DHB | Garden Grove, California | K260280 |
| 2026-06-16 | Diazyme Laboratories, Inc. | Lipoprotein (a) Molarity Assay DFC | Poway, California | K253069 |
| 2026-05-15 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) DHB | Garden Grove, California | K260059 |
| 2026-05-08 | Zeus Scientific | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB OBE | Branchburg, New Jersey | K250814 |
| 2026-04-02 | Roche Diagnostics | Tina-quant Cardiac high sensitivity CRP III NQD | Indianapolis, Indiana | K260026 |
| 2026-03-30 | Centers for Disease Control and Prevention | Francisella tularensis Real-time PCR Assay SGA | Atlanta, Georgia | K260812 |
| 2026-02-06 | Inova Diagnostics, Inc. | Aptiva APS IgA Reagent MSV | San Diego, California | K243979 |
| 2026-01-16 | Hycor Biomedical | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg DHB | Garden Grove, California | K252775 |
| 2026-01-05 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Total PSA II (tPSAII) LTJ | Tarrytown, New York | K251630 |
| 2025-12-23 | DiaSorin, Inc. | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) SGW | Stillwater, Minnesota | DEN250032 |
| 2025-12-23 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) DHB | Garden Grove, California | K252493 |
| 2025-12-19 | Diazyme Laboratories, Inc. | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay DFH | Poway, California | K253358 |
| 2025-12-16 | Fujirebio Diagnostics,Inc. | ADVIA Centaur Cytokeratin Fragment 21-1 OVK | Malvern, Pennsylvania | K250925 |
| 2025-12-04 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroglobulin II (aTgII) JNL | Tarrytown, New Jersey | K250816 |
| 2025-10-22 | Zeus Scientific | Alegria Flash CTD Screen LLL | Branchburg, New Jersey | K250666 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
All device clearancesFDA warning letters
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/immunologyLast updated 2026-10-18
Immunology device clearances: 26 FDA 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/immunology