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
937–960 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS...
K990302 · GIR
Instrumentation Laboratory CO
Hematology · 66d
Cleared Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
K990352 · GKZ
Coulter Corp.
Hematology · 55d
Cleared Mar 31, 1999
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
K990311 · GKZ
Abx Diagnostics
Hematology · 58d
Cleared Mar 23, 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737 · GGT
Nichols Institute Diagnostics
Hematology · 391d
Cleared Mar 19, 1999
AUTOMARQER
K990184 · POV
Hamilton Thorne Research
Hematology · 58d
Cleared Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML),...
K990296 · GJT
Precision Biologic
Hematology · 49d
Cleared Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
K984216 · JPK
Coulter Corp.
Hematology · 112d
Cleared Mar 09, 1999
GTI-PF4 ELISA
K983379 · LCO
Genetic Testing Institute
Hematology · 165d
Cleared Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · JPK
R&D Systems, Inc.
Hematology · 170d
Cleared Feb 17, 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · GJT
Pacific Hemostasis
Hematology · 41d
Cleared Feb 11, 1999
DS30 HCY HOMOCYSTEINE ASSAY KIT
K982003 · LPS
Drew Scientific , Ltd.
Hematology · 248d
Cleared Jan 28, 1999
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · LCP
Osborn Laboratories, Inc.
Hematology · 38d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15...
K981173 · GJT
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15...
K981174 · GJT
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · GGW
Precision Biologicals, Inc.
Hematology · 212d
Cleared Jan 06, 1999
BIOCLOT APC SENSITIVITY
K983898 · GGP
Biopool Intl., Inc.
Hematology · 64d
Cleared Dec 22, 1998
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914 · GGP
Corgenix, Inc.
Hematology · 48d
Cleared Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
K982426 · JBD
Helena Laboratories
Hematology · 157d
Cleared Dec 17, 1998
FERTILMARQ TEST KIT
K983473 · POV
Embryotech Laboratories, Inc.
Hematology · 76d
Cleared Dec 17, 1998
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · LCP
Bio-Rad
Hematology · 17d
Cleared Dec 11, 1998
MAX-ACT
K983649 · JBP
Array Medical, Inc.
Hematology · 56d
Cleared Dec 10, 1998
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · JPK
R&D Systems, Inc.
Hematology · 23d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129 · GIZ
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · GGC
Pacific Hemostasis
Hematology · 13d