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
505–528 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 01, 2005
ITAG MHC TETRAMER CMV ASSAY
K051122 · GKZ
Beckman Coulter, Inc.
Hematology · 91d
Cleared Jul 27, 2005
MS 9/5 HEMATOLOGY ANALYZER
K050436 · GKZ
Melet Schloesing Laboratories USA
Hematology · 155d
Cleared Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · GKZ
Abbott Laboratories
Hematology · 70d
Cleared Jul 12, 2005
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · JPK
R&D Systems, Inc.
Hematology · 50d
Cleared Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
K050053 · JPA
Helena Laboratories
Hematology · 182d
Cleared Jun 29, 2005
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799 · GGN
Biosite Incorporated
Hematology · 91d
Cleared Jun 29, 2005
DADE THROMBIN REAGENT
K050928 · KQJ
Dade Behring, Inc.
Hematology · 76d
Cleared Jun 29, 2005
VISULIZE FACTOR IX ANTIGEN KIT
K051054 · GGP
Affinity Biologicals, Inc.
Hematology · 64d
Cleared Jun 06, 2005
IMMEDIA PROTHROMBIN TIME SYSTEM
K050243 · JPA
Farallon Medial, Inc.
Hematology · 124d
Cleared Jun 01, 2005
ABX ERYTROL
K050721 · JPK
Horiba Abx
Hematology · 72d
Cleared May 24, 2005
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K051040 · JOX
Medtronic Perfusion Systems
Hematology · 29d
Cleared May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 16d
Cleared May 05, 2005
HEMONIR TM
K050014 · GLY
Nir Diagnostics, Inc.
Hematology · 122d
Cleared May 04, 2005
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
K050589 · GKZ
Sysmex America, Inc.
Hematology · 57d
Cleared May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · GJT
Instrumentation Laboratory CO
Hematology · 48d
Cleared Apr 26, 2005
HEMOSIL D-DIMER HS
K050544 · DAP
Instrumentation Laboratory CO
Hematology · 55d
Cleared Apr 26, 2005
ABX PENTRA DX 120: OPTION SPS EVOLUTION
K050719 · GKZ
Horiba Abx
Hematology · 36d
Cleared Apr 01, 2005
MDA B.30
K050513 · JPA
bioMerieux, Inc.
Hematology · 31d
Cleared Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
K050221 · GFO
Instrumentation Laboratory CO
Hematology · 58d
Cleared Mar 23, 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235 · GKL
Iris International, Inc.
Hematology · 50d
Cleared Mar 18, 2005
CRYOCHECK CLOT S
K043571 · GGP
Precision Biologic, Inc.
Hematology · 81d
Cleared Mar 17, 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
K043451 · GGN
Hyphen Biomed
Hematology · 93d
Cleared Mar 10, 2005
HEMOSIL D-DIMER
K050278 · DAP
Instrumentation Laboratory CO
Hematology · 31d
Cleared Feb 22, 2005
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
K050191 · PER
Becton, Dickinson & CO
Hematology · 26d