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

625–648 of 3,297

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

Cleared Jul 02, 2003

Belmont Instrument Corp.

Hematology · 51d

Cleared Jun 27, 2003

K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090

Kamiya Biomedical Co.

Hematology · 114d

Cleared Jun 06, 2003

CALIBRATION PLASMA LMW HEPARIN

Instrumentation Laboratory CO

Hematology · 71d

Cleared Jun 06, 2003

CONTROL PLASMA LMW HEPARIN

Instrumentation Laboratory CO

Hematology · 71d

Cleared May 22, 2003

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

Roche Diagnostics Corp.

Hematology · 66d

Cleared May 21, 2003

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)

Beckman Coulter, Inc.

Hematology · 68d

Cleared May 19, 2003

HEMOSIL FACTOR X DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 41d

Cleared May 12, 2003

CELL-DYN 1800 SYSTEM

Abbott Laboratories

Hematology · 82d

Cleared Apr 28, 2003

CHROMOCHECK ANTITHROMBIN 25

Precision Biologic

Hematology · 146d

Cleared Apr 21, 2003

COULTER LH 750 BODY FLUIDS APPLICATION

Beckman Coulter, Inc.

Hematology · 55d

Cleared Apr 17, 2003

COULTER ACT 5DIFF AUTOLOADER (AL)

Beckman Coulter, Inc.

Hematology · 79d

Cleared Apr 11, 2003

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

Hematology · 70d

Cleared Apr 11, 2003

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A

Hematology · 49d

Cleared Apr 08, 2003

Abx Diagnostics

Hematology · 26d

Cleared Apr 02, 2003

Care Products, Inc.

Hematology · 71d

Cleared Apr 02, 2003

HEMOCHRON RESPONSE/SYSTEM

International Technidyne Corp.

Hematology · 19d

Cleared Apr 01, 2003

MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM

Roche Diagnostics Corp.

Hematology · 22d

Cleared Mar 19, 2003

CHROMOCHECK PROTEIN C 25

Precision Biologic

Hematology · 106d

Cleared Mar 19, 2003

HEMOSIL FACTOR XI DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 50d

Cleared Mar 04, 2003

CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...

Beckman Coulter, Inc.

Hematology · 25d

Cleared Feb 24, 2003

LIQUICHEK D-DIMER CONTROL, MODEL 356, 357

Hematology · 38d

Cleared Feb 14, 2003

PLATELETWORKS, MODELS PW-A, PW-C

Helena Laboratories

Hematology · 98d

Cleared Feb 12, 2003

HEMOSIL FACTOR VII DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 63d

Cleared Jan 31, 2003

ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

International Technidyne Corp.

Hematology · 100d