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
1561–1584 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 26, 1992
COAG-CONTROL [N] KIT
K922174 · GGN
American Bioproducts Co.
Hematology · 171d
Cleared Oct 26, 1992
IL TEST PT FIBRINOGEN HS
K923921 · GIS
Instrumentation Laboratory CO
Hematology · 82d
Cleared Oct 19, 1992
PLATELIN L
K921396 · GFO
Organon Teknika Corp.
Hematology · 210d
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