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Hematology device clearances

Every FDA 510(k) decision for hematology devices in the last 12 months: the applicant, the device, where it is made and FDA's own record.

Decisions13
Applicants11
Latest2026-09-24

FDA decided 13 premarket notifications (510(k)s) for hematology devices from 11 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.

DecidedApplicantDeviceWhereRecord
2026-09-24Diagnostica Stago, Inc.STA® - Liquid Anti-Xa KFFParsippany, New JerseyK260214
2026-09-14HORIBA ABX SASYumizen H550 GKZFRK260781
2026-08-11Siemens Healthcare Diagnostic Products GmbHINNOVANCE® D-Dimer 2.0 (SMN 10873803) DAPDEK253985
2026-07-02Optrascan, Inc.OptraSCAN System NOTSan Jose, CaliforniaK260755
2026-06-18Daxor CorporationBlood Volume Analyzer (200) JWOOak Ridge, TennesseeK261099
2026-05-27Sysmex America, Inc.XR-Series (XR-10, XR-20) Automated Hematology Analyzers GKZLincolnshire, IllinoisK253212
2026-04-27Diagnostica Stago, Inc.STA Satellite Max® JPAParsippany, New JerseyK253658
2026-04-09Checkcells, Inc.Seaman Pro/Seaman POVSanta Monica, CaliforniaK252228
2026-03-20Instrumentation Laboratory (IL) Co.HemosIL Factor V Leiden (APC Resistance V) GGWBedford, MassachusettsK260551
2026-02-06Athelas, Inc.Athelas Home GKZMountain View, CaliforniaK243348
2026-01-16Truvian Sciences, Inc.Tru Hematology Test GKZSan Diego, CaliforniaK251249
2026-01-09Instrumentation Laboratory (IL) Co.HemosIL Silica Clotting Time GFOBedford, MassachusettsK253957
2025-10-24Roche DiagnosticsCoaguChek XS Plus System GJSIndianapolis, IndianaK253188

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/hematology
Last updated 2026-10-18
Hematology device clearances: 13 FDA 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/hematology