Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×

3,297 results

961–984 of 3,297

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

Cleared Dec 01, 1998

COAGULATION CONTROL LEVEL 3 (ABNORMAL)

Pacific Hemostasis

Hematology · 13d

Cleared Nov 30, 1998

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

Diabetes Technologies, Inc. (Dti)

Hematology · 81d

Cleared Nov 20, 1998

PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT

Medisense, Inc.

Hematology · 65d

Cleared Nov 12, 1998

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER

American Bioproducts Co.

Hematology · 43d

Cleared Nov 09, 1998

CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...

Hematology · 143d

Cleared Nov 05, 1998

CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...

Hematology · 139d

Cleared Nov 03, 1998

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500

Hematology · 153d

Cleared Nov 03, 1998

COAMATIC HEPARIN

Instrumentation Laboratory CO

Hematology · 53d

Cleared Nov 03, 1998

MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

Cdc Technologies, Inc.

Hematology · 21d

Cleared Oct 22, 1998

Ramco Laboratories, Inc.

Hematology · 48d

Cleared Oct 16, 1998

TRACCELL 2000 SLIDE MAPPING SYSTEM

Accumed Intl., Inc.

Hematology · 67d

Cleared Oct 15, 1998

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589

Sigma Diagnostics, Inc.

Hematology · 114d

Cleared Oct 13, 1998

COAGULATION FACTOR V DEFICIENT PLASMA

Dade Behring, Inc.

Hematology · 162d

Cleared Sep 30, 1998

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT

International Technidyne Corp.

Hematology · 422d

Cleared Sep 30, 1998

Avocet Medical, Inc.

Hematology · 210d

Cleared Sep 30, 1998

SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

Dade Behring, Inc.

Hematology · 156d

Cleared Sep 28, 1998

COAMATIC PLASMIN INHIBITOR

Instrumentation Laboratory CO

Hematology · 129d

Cleared Sep 24, 1998

CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH...

Hematology · 97d

Cleared Sep 22, 1998

BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Hematology · 43d

Cleared Sep 15, 1998

Aerscher Diagnostics

Hematology · 132d

Cleared Aug 27, 1998

IL TEST PLASMIN INHIBITOR

Instrumentation Laboratory CO

Hematology · 105d

Cleared Aug 21, 1998

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

Shield Diagnostics, Ltd.

Hematology · 165d

Cleared Aug 21, 1998

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800

Cdc Technologies, Inc.

Hematology · 112d

Cleared Aug 14, 1998

SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER

Hematology · 87d