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

1729–1752 of 3,297

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

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

Cleared Feb 07, 1991

ABBOTT VISION(TM) GLYCATED HB

Abbott Laboratories

Hematology · 161d

Cleared Jan 25, 1991

COAG-1 PT-NC TEST CARD

Cardiovascular Diagnostic Services

Hematology · 127d

Cleared Jan 24, 1991

LIATEST(R) AT III TEST KIT

American Bioproducts Co.

Hematology · 72d

Cleared Jan 18, 1991

FREE PROTEIN S REAGENT CAT. NO. 5363

Helena Laboratories

Hematology · 126d

Cleared Dec 31, 1990

FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM

Bd Becton Dickinson Vacutainer...

Hematology · 73d

Cleared Dec 28, 1990

COAGULATION REFERENCE PLASMA, NORMAL

Medical Diagnostic Technologies, Inc.

Hematology · 38d

Cleared Dec 27, 1990

NEW COBE SATURATION/HEMATOCRIT MONITOR

Cobe Laboratories, Inc.

Hematology · 98d

Cleared Dec 17, 1990

LUPO-TEST REAGENT

Gradipore , Ltd.

Hematology · 159d

Cleared Dec 17, 1990

ANTI-HUMAN LEU-2A (CD8) PE

Bd Becton Dickinson Vacutainer...

Hematology · 83d

Cleared Dec 17, 1990

HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION

International Technidyne Corp.

Hematology · 91d

Cleared Dec 11, 1990

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE

Bd Becton Dickinson Vacutainer...

Hematology · 90d

Cleared Nov 29, 1990

HEMOCHRON(R) HEPARIN RESPONSE TEST

Intensive Technology, Inc.

Hematology · 92d

Cleared Nov 13, 1990

ST-4 COAGULATION INSTRUMENT

American Bioproducts Co.

Hematology · 55d

Cleared Nov 08, 1990

ELVI 828 DIGICLOT MULTISCAN

Logos Scientific, Inc.

Hematology · 148d

Cleared Nov 08, 1990

Sigma Chemical Co.

Hematology · 49d

Cleared Nov 05, 1990

MONOHAEM (FECAL OCCULT BLOOD TEST)

Silenus Laboratories Proprietary , Ltd.

Hematology · 243d

Cleared Nov 02, 1990

QBC SYSTEM MCHC

Bd Becton Dickinson Vacutainer...

Hematology · 21d

Cleared Nov 01, 1990

THROMBELASTOGRAPH

Haemoscope Corp.

Hematology · 50d

Cleared Oct 29, 1990

QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE

R&D Systems, Inc.

Hematology · 18d

Cleared Oct 26, 1990

DSL ERYTHROPOIETIN (DSL # 1100)

Diagnostic Systems Laboratories, Inc.

Hematology · 84d

Cleared Oct 23, 1990

CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED

R&D Systems, Inc.

Hematology · 22d