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
1657–1680 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD3
K901189 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
K910473 · GKZ
Coulter Immunology
Hematology · 269d
Cleared Oct 31, 1991
THROMBONOSTIKA F1.2
K911434 · MIF
Organon Teknika Corp.
Hematology · 212d
Cleared Oct 31, 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · LCP
Binax, Inc.
Hematology · 132d
Cleared Oct 18, 1991
QBC E-Z PREP
K913399 · JKA
Bd Becton Dickinson Vacutainer...
Hematology · 80d
Cleared Oct 18, 1991
HEMOCHRON(R) KACT
K913861 · JBP
International Technidyne Corp.
Hematology · 52d
Cleared Oct 09, 1991
HEMOCARD HEMOGLOBIN S
K911981 · GHM
Isolab, Inc.
Hematology · 159d
Cleared Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
K912711 · GGP
Instrumentation Laboratory CO
Hematology · 112d
Cleared Oct 09, 1991
FIBRINOSTIKA FBDP MICROELISA SYSTEM
K912876 · DAP
Organon Teknika Corp.
Hematology · 100d
Cleared Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
K913061 · GIS
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Oct 08, 1991
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
K913259 · GKZ
Nova Biomedical Corp.
Hematology · 77d
Cleared Oct 08, 1991
STACLOT(R) PROTEIN S TEST KIT
K913424 · GGP
American Bioproducts Co.
Hematology · 68d
Cleared Oct 04, 1991
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · KHE
Labeltape Meditect, Inc.
Hematology · 123d
Cleared Oct 02, 1991
LIATEST PROTEIN S KIT
K912468 · GGP
American Bioproducts Co.
Hematology · 120d
Cleared Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
K912615 · GZI
Roche Diagnostic Systems, Inc.
Hematology · 106d
Cleared Sep 23, 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
K905709 · LCP
Beckman Instruments, Inc.
Hematology · 276d
Cleared Sep 23, 1991
HEMATASTAT C-70B
K913128 · GKG
Separation Technology, Inc.
Hematology · 136d
Cleared Sep 19, 1991
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
K912087 · JPA
Instrumentation Laboratory CO
Hematology · 129d
Cleared Sep 16, 1991
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K913005 · JIO
Remel Co.
Hematology · 70d
Cleared Sep 13, 1991
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
K911626 · GKZ
Serono Baker Diagnostics System
Hematology · 155d
Cleared Sep 10, 1991
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
K912494 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 97d
Cleared Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · GJT
Baxter Healthcare Corp
Hematology · 84d
Cleared Sep 05, 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · LCP
Heraeus Kulzer, Inc.
Hematology · 147d