FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×

3,294 results

1705–1728 of 3,294

Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology

Cleared May 28, 1991

Streck Laboratories, Inc.

Hematology · 50d

Cleared May 20, 1991

ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY

Ortho Diagnostic Systems, Inc.

Hematology · 248d

Cleared May 20, 1991

EPINEPHRINE REAGENT, CAT. NO. 5367

Helena Laboratories

Hematology · 94d

Cleared May 20, 1991

COLLAGEN REAGENT CAT. NO. 5368

Helena Laboratories

Hematology · 89d

Cleared May 20, 1991

Helena Laboratories

Hematology · 84d

Cleared May 10, 1991

HITT BY HEMOCHRON(R)

International Technidyne Corp.

Hematology · 114d

Cleared May 07, 1991

GENESIS I AUTOMATED CELL COUNTER

Alicia Diagnostics, Inc.

Hematology · 81d

Cleared May 07, 1991

Bd Becton Dickinson Vacutainer...

Hematology · 69d

Cleared May 06, 1991

FHT (FECAL HEME TEST)

Hematology · 136d

Cleared Apr 29, 1991

Hematology · 75d

Cleared Apr 29, 1991

HEPARIN CONTROLS, HIGH AND LOW

Sigma Diagnostics, Inc.

Hematology · 67d

Cleared Apr 16, 1991

HELENA THROMBOPLASTIN REAGENT WITH DILUENT

Helena Laboratories

Hematology · 110d

Cleared Apr 15, 1991

Hematology · 73d

Cleared Apr 12, 1991

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY

Agen Biomedical , Ltd.

Hematology · 116d

Cleared Apr 12, 1991

DANAM DATACELL-18

Danam Electronics

Hematology · 79d

Cleared Apr 03, 1991

FLOW CYTOMETRY FITC/PE COMPENSATION KIT

Sigma Diagnostics, Inc.

Hematology · 71d

Cleared Mar 19, 1991

PLATELET AGGREGATION REAGENTS

Medical Diagnostic Technologies, Inc.

Hematology · 56d

Cleared Mar 11, 1991

HEMOCARD CONTROL

Hematology · 38d

Cleared Feb 27, 1991

HELENA THROMBOPLASTIN REAGENT, MODIFICATION

Helena Laboratories

Hematology · 75d

Cleared Feb 26, 1991

DADE PROTEIN C CLOTTING ASSAY

Baxter Healthcare Corp

Hematology · 209d

Cleared Feb 26, 1991

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200

International Technidyne Corp.

Hematology · 54d

Cleared Feb 20, 1991

Streck Laboratories, Inc.

Hematology · 72d

Cleared Feb 14, 1991

FIBRINOTEST(TM) - FIBRINOGEN ASSAY

Haemachem, Inc.

Hematology · 176d

Cleared Feb 11, 1991

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183

Helena Laboratories

Hematology · 55d