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

1609–1632 of 3,297

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

Cleared Jun 09, 1992

GLYCO-TEK AFFINITY COLUMN KIT

Helena Laboratories

Hematology · 89d

Cleared Jun 09, 1992

THROMBO-CALIBRATOR KIT

American Bioproducts Co.

Hematology · 82d

Cleared Jun 09, 1992

Helena Laboratories

Hematology · 81d

Cleared Jun 09, 1992

AVK CONTROL I & II

American Bioproducts Co.

Hematology · 63d

Cleared Jun 09, 1992

PTT-LA TEST KIT

American Bioproducts Co.

Hematology · 62d

Cleared Jun 09, 1992

UNICALIBRATOR KIT

American Bioproducts Co.

Hematology · 40d

Cleared Jun 04, 1992

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

Baxter Diagnostics, Inc.

Hematology · 99d

Cleared May 31, 1992

Streck Laboratories, Inc.

Hematology · 90d

Cleared May 15, 1992

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5

Heraeus Kulzer, Inc.

Hematology · 74d

Cleared May 11, 1992

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA

Baxter Diagnostics, Inc.

Hematology · 161d

Cleared May 01, 1992

YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU

Intl. Remote Imaging Systems

Hematology · 221d

Cleared May 01, 1992

THROMBIN CLOTTING TIME REAGENT

Helena Laboratories

Hematology · 109d

Cleared Apr 29, 1992

SYSMEX HEMATOLOGY SYSTEM ACCESSORIES

Toa Medical Electronics USA, Inc.

Hematology · 83d

Cleared Apr 29, 1992

CRITSPIN MICRO-HEMATOCRIT

Stat-Spin Technologies

Hematology · 70d

Cleared Apr 29, 1992

Innovative Medical Systems, Inc.

Hematology · 57d

Cleared Apr 17, 1992

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA

Medical Diagnostic Technologies, Inc.

Hematology · 46d

Cleared Mar 11, 1992

MARATHON 6K GENERAL-PURPOSE CENTRIFUGE

Fisher Scientific Co., LLC

Hematology · 72d

Cleared Mar 04, 1992

COAGULATION ARPR,CAT.NO.5185

Helena Laboratories

Hematology · 121d

Cleared Mar 04, 1992

FIBRINOGEN CONTROL

Sigma Diagnostics, Inc.

Hematology · 91d

Cleared Feb 18, 1992

ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.

Mbo Laboratories, Inc.

Hematology · 34d

Cleared Feb 14, 1992

ELLAGIC ACID APTT REAGENT

Helena Laboratories

Hematology · 74d

Cleared Feb 12, 1992

Organon Teknika Corp.

Hematology · 51d

Cleared Feb 11, 1992

HEMOCHRON ONESTEP APTT TEST

International Technidyne Corp.

Hematology · 77d

Cleared Feb 06, 1992

SIMULTEST(TM) IMK-LYMPHOCYTE

Bd Becton Dickinson Vacutainer...

Hematology · 203d