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
1777–1800 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 20, 1990
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
K901874 · KFF
Kabi Diagnostica
Hematology · 85d
Cleared Jul 03, 1990
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
K902081 · JBP
Hemotec, Inc.
Hematology · 56d
Cleared Jul 03, 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · GJS
Sigma Chemical Co.
Hematology · 56d
Cleared Jul 03, 1990
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
K902210 · GGN
Ortho Diagnostic Systems, Inc.
Hematology · 48d
Cleared Jul 03, 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · JIW
Sigma Chemical Co.
Hematology · 42d
Cleared Jun 20, 1990
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
K902028 · JPI
Norfolk Scientific, Inc.
Hematology · 47d
Cleared Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414 · LCP
Helena Laboratories
Hematology · 81d
Cleared Jun 15, 1990
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
K902083 · GJT
Helena Laboratories
Hematology · 39d
Cleared May 30, 1990
PARA 12 PLUS
K901875 · JCN
Streck Laboratories, Inc.
Hematology · 34d
Cleared May 25, 1990
ORTHO CORRECTION REAGENTS
K901327 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 65d
Cleared May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380 · GKP
Helena Laboratories
Hematology · 64d
Cleared May 23, 1990
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K901143 · JBD
Helena Laboratories
Hematology · 72d
Cleared May 22, 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · GKP
Ortho Diagnostic Systems, Inc.
Hematology · 71d
Cleared May 16, 1990
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
K900939 · KQJ
Incstar Corp.
Hematology · 77d
Cleared May 15, 1990
ANTI-HUMAN LEU-3A (CD4) FITC
K900802 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 84d
Cleared May 02, 1990
THROMBOPLASTIN.C PLUS
K901325 · GJS
Baxter Healthcare Corp
Hematology · 42d
Cleared Apr 16, 1990
EXACT ONE(TM) HEMATOLOGY ANALYZER
K900276 · GKZ
Exact Science, Inc.
Hematology · 87d
Cleared Apr 16, 1990
RDW AND MPV INDICES ON HEMAT 12
K900684 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 63d
Cleared Apr 16, 1990
CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
K900685 · KQG
Texas Intl. Laboratories, Inc.
Hematology · 63d
Cleared Apr 16, 1990
COAG-A-MATE - RA4
K900895 · KQJ
Organon Teknika Corp.
Hematology · 48d
Cleared Apr 16, 1990
COAG-A-MATE - RA4
K900917 · JPA
Organon Teknika Corp.
Hematology · 48d
Cleared Apr 11, 1990
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · GGC
Ortho Diagnostic Systems, Inc.
Hematology · 28d
Cleared Apr 02, 1990
SIMULTEST IMK PLUS(TM)
K900078 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 88d
Cleared Mar 30, 1990
COULTER JT3
K896873 · GKZ
Coulter Corp.
Hematology · 112d