FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
1873–1896 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 15, 1989
HGB-CONTROL SET/MULTIPLE
K893985 · GGM
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 03, 1989
QBC MALARIA SYSTEM
K891276 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 147d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Abbott Laboratories
Hematology · 63d
Cleared Aug 03, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
K894425 · GGC
Analytical Control Systems, Inc.
Hematology · 17d
Cleared Jul 27, 1989
CHARISE CHARLES REAGENT BLOOD STRIPS
K893894 · JIO
Lee Import Domestic Consulting
Hematology · 58d
Cleared Jul 27, 1989
ELECTRA 1000C AUTOMATIC COAGULATION TIMER
K894052 · GKP
Medical Laboratory Automation...
Hematology · 50d
Cleared Jul 25, 1989
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
K893895 · JPK
Intercare Diagnostics, Inc.
Hematology · 56d
Cleared Jul 25, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
K893970 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
K894338 · GGC
Analytical Control Systems, Inc.
Hematology · 11d
Cleared Jul 14, 1989
A.QC HCT LEVEL 1 AND 2
K893562 · GLK
Johnson & Johnson Professionals, Inc.
Hematology · 66d
Cleared Jun 23, 1989
THROMBOSTIN IFA*
K885107 · GJS
Investigacion Farmaceutica S.A. DE C.V.
Hematology · 193d
Cleared Jun 23, 1989
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · GGP
American Bioproducts Co.
Hematology · 66d
Cleared Jun 23, 1989
FACTOR X DEFICIENT PLASMA
K893523 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR IX DEFICIENT PLASMA
K893524 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VIII DEFICIENT PLASMA
K893525 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR V DEFICIENT PLASMA
K893533 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XII DEFICIENT PLASMA
K893534 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VII DEFICIENT PLASMA
K893535 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XI DEFICIENT PLASMA
K893536 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
ACTICHROME ATIII KIT
K893608 · JBQ
American Diagnostic Corp.
Hematology · 44d
Cleared Jun 23, 1989
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · JPA
Bio/Data Corp.
Hematology · 39d
Cleared Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d