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
1561–1584 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 16, 1992
MINUTEX D-DIMER LATEX TEST
K920668 · GHH
Biopool AB
Hematology · 246d
Cleared Oct 14, 1992
COULTER MULTI-Q-PREP
K923530 · GKH
Coulter Electronics, Inc.
Hematology · 90d
Cleared Oct 09, 1992
SPECTROLYSE/PL PAI KIT
K922782 · GGP
Biopool AB
Hematology · 122d
Cleared Oct 05, 1992
PROPPER SUPER SERACULT(R)
K921798 · KHE
Propper Mfg. Co., Inc.
Hematology · 174d
Cleared Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
K921831 · LCP
Abbott Laboratories
Hematology · 166d
Cleared Sep 29, 1992
THROMBIN CLOT TIME TEST PROCEDURE
K923220 · GJA
Medical Laboratory Automation...
Hematology · 90d
Cleared Sep 25, 1992
HEMOLAB SILIMAT REAGENT
K920001 · GFI
Biomerieux Vitek, Inc.
Hematology · 267d
Cleared Sep 23, 1992
NEW STACHROM ANTIPLASMIN
K921449 · GGP
American Bioproducts Co.
Hematology · 181d
Cleared Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
K923121 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 88d
Cleared Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · KQJ
International Technidyne Corp.
Hematology · 64d
Cleared Sep 21, 1992
CLOTTRAC COAGULATION CONTROL
K923594 · JBP
Medtronic Hemotec, Inc.
Hematology · 63d
Cleared Sep 11, 1992
TECHNICON H*2
K923237 · GKZ
Heraeus Kulzer, Inc.
Hematology · 71d
Cleared Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
K923322 · CIX
Trace Scientific , Ltd.
Hematology · 66d
Cleared Aug 26, 1992
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
K914188 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 343d
Cleared Aug 26, 1992
PLATELET AGGREGATION REAGENTS
K922800 · GHR
Chrono-Log Corp.
Hematology · 77d
Cleared Aug 25, 1992
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · JPD
Helena Laboratories
Hematology · 49d
Cleared Aug 25, 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · JPD
Helena Laboratories
Hematology · 49d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
K922680 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 77d
Cleared Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
K921223 · GFO
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Aug 17, 1992
MODIFICATION COLUMNMATE
K920820 · LCP
Helena Laboratories
Hematology · 186d
Cleared Aug 17, 1992
COULTER MH009
K922181 · GKZ
Coulter Electronics, Inc.
Hematology · 101d
Cleared Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012 · GGP
Instrumentation Laboratory CO
Hematology · 223d
Cleared Aug 12, 1992
DENLEY WELLPREP 2 SAMPLE PROCESSOR
K922327 · JQW
Denley Instruments, Inc.
Hematology · 93d
Cleared Aug 05, 1992
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698 · DAP
Organon Teknika Corp.
Hematology · 226d