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
1873–1896 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 05, 1989
THROMBIN TIME REAGENT
K894467 · GJA
Sigma Chemical Co.
Hematology · 49d
Cleared Aug 15, 1989
COULTER CLONE MO2
K884605 · GKZ
Coulter Immunology
Hematology · 285d
Cleared Aug 15, 1989
HGB-CAL SET/MULTIPLE
K893984 · KRZ
R&D Systems, Inc.
Hematology · 71d
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