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
553–576 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 18, 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · GGN
Medtronic Vascular
Hematology · 68d
Cleared Oct 18, 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · GGN
Medtronic Vascular
Hematology · 63d
Cleared Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · JPK
Bio-Rad Laboratories, Inc.
Hematology · 45d
Cleared Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
K042173 · GKZ
Beckman Coulter, Inc.
Hematology · 62d
Cleared Oct 06, 2004
VERIFYNOW-ASPIRIN ASSAY
K042423 · JOZ
Accumetrics, Inc.
Hematology · 29d
Cleared Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · JOX
Medtronic Vascular
Hematology · 60d
Cleared Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
K041905 · JIX
Instrumentation Laboratory CO
Hematology · 75d
Cleared Sep 17, 2004
BD FACSCANTO WITH BD FACSANTO SOFTWARE
K041074 · GKZ
Bd Biosciences
Hematology · 144d
Cleared Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · GKZ
Bayer Healthcare, LLC
Hematology · 28d
Cleared Sep 16, 2004
DUET SYSTEM
K040591 · JOY
Bioview , Ltd.
Hematology · 192d
Cleared Sep 10, 2004
BD FACS 7-COLOR SETUP BEADS
K040026 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 247d
Cleared Sep 10, 2004
BD FACSCANTO SYSTEM
K040725 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 172d
Cleared Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
K033491 · DAP
Roche Diagnostics Corp.
Hematology · 302d
Cleared Sep 01, 2004
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
K041502 · JOZ
Haemoscope Corp.
Hematology · 86d
Cleared Sep 01, 2004
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Aug 12, 2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · KHE
W.H.P.M., Inc.
Hematology · 97d
Cleared Aug 12, 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · KHE
Polymedco, Inc.
Hematology · 90d
Cleared Aug 11, 2004
ADVANCED D-DIMER ASSAY
K041438 · DAP
Dade Behring, Inc.
Hematology · 71d
Cleared Jul 27, 2004
CYTO-CHEX BCT
K040107 · JKA
Streck Laboratories, Inc.
Hematology · 189d
Cleared Jul 27, 2004
QWIKCHECK-BEADS
K041600 · NRF
Medical Electronics Systems , Ltd.
Hematology · 43d
Cleared Jul 12, 2004
DIAPHARMA FACTOR X KIT
K040362 · GJT
Diapharma Group, Inc.
Hematology · 150d
Cleared Jun 28, 2004
CELLSEARCH EPITHELIAL CELL CONTROL KIT
K040898 · NRS
Veridex, LLC
Hematology · 83d
Cleared Jun 28, 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · JPK
Bio-Rad
Hematology · 27d
Cleared Jun 18, 2004
CRYOCHECK CLOT C
K040987 · GGP
Precision Biologic, Inc.
Hematology · 64d