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
1777–1800 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 24, 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455 · LCP
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 24, 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
K902457 · LCP
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 23, 1990
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
K902263 · GGX
Trimedyne, Inc.
Hematology · 63d
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