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
385–408 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 19, 2007
PF4 IGG
K071781 · LCO
Genetic Testing Institute
Hematology · 170d
Cleared Dec 11, 2007
D3 HEMATOLOGY ANALYZER, MODEL D3
K071562 · GKZ
Drew Scientific, Inc.
Hematology · 187d
Cleared Nov 30, 2007
SMARTCHECK INR SYSTEM
K071265 · JPA
Inverness Medical Innovations, Inc.
Hematology · 207d
Cleared Nov 26, 2007
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · JPK
R&D Systems, Inc.
Hematology · 53d
Cleared Nov 20, 2007
SYSMEX XE-5000
K071967 · GKZ
Sysmex America, Inc.
Hematology · 127d
Cleared Nov 20, 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · JPK
R&D Systems, Inc.
Hematology · 97d
Cleared Oct 26, 2007
INRATIO 2 PT MONITORING SYSTEM
K072727 · GJS
Hemosense, Inc.
Hematology · 30d
Cleared Oct 25, 2007
HEMOCUE WBC SYSTEM
K071652 · GKL
Hemocue AB
Hematology · 129d
Cleared Oct 25, 2007
GENERAL SEMEN ANALYSIS KIT
K071737 · POV
Dyn-Bioshaf (2006) , Ltd.
Hematology · 121d
Cleared Oct 11, 2007
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR...
K070597 · NSU
Nanosphere, Inc.
Hematology · 223d
Cleared Oct 11, 2007
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934 · JQC
Biomet Manufacturing Corp
Hematology · 90d
Cleared Oct 04, 2007
SCANVIEW, MODEL SC-300
K071398 · JOY
Applied Spectral Imaging , Ltd.
Hematology · 136d
Cleared Oct 04, 2007
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
K071681 · GKZ
Beckman Coulter, Inc.
Hematology · 107d
Cleared Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
K072304 · GFX
Dade Behring, Inc.
Hematology · 33d
Cleared Sep 17, 2007
HEMOSIL D-DIMER HS
K070927 · DAP
Instrumentation Laboratory CO
Hematology · 167d
Cleared Sep 07, 2007
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
K071255 · LCO
Hyphen Biomed
Hematology · 126d
Cleared Aug 20, 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · JPK
R&D Systems, Inc.
Hematology · 20d
Cleared Aug 15, 2007
SPECTROLYSE PAI-1, MODEL 101201
K063323 · GGP
American Diagnostica, Inc.
Hematology · 285d
Cleared Aug 15, 2007
HEMOSIL RECOMBIPLASTIN 2G
K070005 · GJS
Instrumentation Laboratory CO
Hematology · 224d
Cleared Jul 10, 2007
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
K063357 · JKA
Greiner Bio-One North America, Inc.
Hematology · 245d
Cleared Jun 26, 2007
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS...
K071319 · GGN
Bio-Rad, Diagnostics Grp.
Hematology · 47d
Cleared Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · KHE
Alfa Scientific Designs, Inc.
Hematology · 104d
Cleared Jun 20, 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
K070666 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 100d
Cleared Jun 11, 2007
BC-3200 AUTO HEMATOLOGY ANALYZER
K063407 · GKZ
Shenzhen Mindray Bio-Medical...
Hematology · 214d