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
1465–1488 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 30, 1993
TRACE TRANSFERRIN REAGENT
K932713 · DDQ
Trace Scientific , Ltd.
Hematology · 118d
Cleared Sep 27, 1993
BIOCLOT LA
K932463 · GIR
Biopool AB
Hematology · 129d
Cleared Sep 22, 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · JPA
Baxter Diagnostics, Inc.
Hematology · 84d
Cleared Sep 15, 1993
BIOMERIEUX HEMOLAB COFAC VIII
K933010 · GJT
Biomerieux Vitek, Inc.
Hematology · 86d
Cleared Sep 09, 1993
745 GLYCOMAT
K933287 · LCP
Drew Scientific , Ltd.
Hematology · 65d
Cleared Sep 02, 1993
HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION
K930068 · JPA
Technidyne Corp.
Hematology · 239d
Cleared Sep 02, 1993
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
K930235 · GGP
Technidyne Corp.
Hematology · 240d
Cleared Sep 01, 1993
FACSORT FLOW CYTOMETER
K923790 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 400d
Cleared Aug 23, 1993
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · GKZ
Coulter Corp.
Hematology · 182d
Cleared Aug 23, 1993
ELECTRA 1600C AUTOMATIC COAGULATION TIMER
K931206 · GKP
Medical Laboratory Automation...
Hematology · 166d
Cleared Aug 23, 1993
CASCADE M, CAT. NO. 1710
K931956 · GKP
Helena Laboratories
Hematology · 125d
Cleared Aug 23, 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · GKZ
Coulter Corp.
Hematology · 118d
Cleared Aug 19, 1993
PROTEIN-BOUND GLUCOSE ASSAYN KIT
K930823 · LCP
Diagnostic Specialties
Hematology · 183d
Cleared Aug 16, 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K931503 · JBD
Helena Laboratories
Hematology · 144d
Cleared Aug 16, 1993
SICKLE CELL TEST KIT
K932872 · JBB
Histo-Med, Inc.
Hematology · 63d
Cleared Aug 13, 1993
IL TEST FIBRINOGEN-C
K931721 · KQJ
Instrumentation Laboratory CO
Hematology · 128d
Cleared Aug 09, 1993
STACLOT(R) PNP TEST KIT
K924370 · GGW
American Bioproducts Co.
Hematology · 346d
Cleared Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · LGS
Abbott Laboratories
Hematology · 98d
Cleared Aug 05, 1993
SIMULTEST CD3/ANTI-HLA-DR
K924587 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 329d
Cleared Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · JPA
Boehringer Mannheim Corp.
Hematology · 190d
Cleared Jul 23, 1993
IMS-200
K925670 · JOY
Intelligent Medica Imaging, Inc.
Hematology · 255d
Cleared Jul 20, 1993
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666 · GGT
R&D Systems, Inc.
Hematology · 105d
Cleared Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · GKZ
Abbott Laboratories
Hematology · 174d
Cleared Jul 06, 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · GKZ
Coulter Corp.
Hematology · 214d