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
481–504 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 29, 2005
ABX MICROS CRP 200, OPTION IM
K053308 · GKZ
Horiba Abx
Hematology · 31d
Cleared Dec 27, 2005
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
K050365 · GGP
Hyphen Biomed
Hematology · 316d
Cleared Dec 23, 2005
COAG-A-MATE MTX III
K051030 · JPA
bioMerieux, Inc.
Hematology · 245d
Cleared Dec 23, 2005
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH...
K051472 · GGN
Hyphen Biomed
Hematology · 203d
Cleared Dec 22, 2005
CHEMPAQ XBC ANALYZER
K050758 · GKZ
Chempaq A/S
Hematology · 274d
Cleared Dec 12, 2005
T-TEK
K050817 · GJA
R2 Diagnostics, Inc.
Hematology · 256d
Cleared Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · GKL
Bayer Healthcare, LLC
Hematology · 167d
Cleared Dec 07, 2005
EXTENDSURE HBFASC CONTROL
K053031 · JCM
Cantebury Scientific , Ltd.
Hematology · 41d
Cleared Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
K052905 · GKZ
Beckman Coulter, Inc.
Hematology · 35d
Cleared Nov 07, 2005
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
K043007 · JBQ
Hyphen Biomed
Hematology · 371d
Cleared Oct 17, 2005
ACTICLOT, MODEL 824
K052124 · GJS
American Diagnostica, Inc.
Hematology · 73d
Cleared Oct 14, 2005
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265 · JOZ
Chrono-Log Corp.
Hematology · 252d
Cleared Oct 13, 2005
BELMONT BUDDY FLUID WARMER
K052547 · BSB
Belmont Instrument Corp.
Hematology · 27d
Cleared Oct 03, 2005
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · KHE
Epitope Diagnostics, Inc.
Hematology · 90d
Cleared Sep 23, 2005
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
K050448 · GGP
Horiba Abx
Hematology · 213d
Cleared Sep 23, 2005
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
K051459 · GKZ
Sysmex America, Inc.
Hematology · 113d
Cleared Aug 31, 2005
MS 4/5 HEMATOLOGY ANALYZER
K050421 · GKZ
Melet Schloesing Laboratories USA
Hematology · 194d
Cleared Aug 17, 2005
STRATUS CS D-DIMER
K051597 · DAP
Dade Behring, Inc.
Hematology · 62d
Cleared Aug 17, 2005
IQ BODY FLUIDS CONTROL
K051706 · JPK
Streck
Hematology · 51d
Cleared Aug 16, 2005
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
K050821 · KQG
Zycare
Hematology · 138d
Cleared Aug 16, 2005
MODIFICATION TO DUET SYSTEM
K050840 · JOY
Bioview , Ltd.
Hematology · 137d
Cleared Aug 16, 2005
CD-CHEX PLUS BC
K051633 · GGL
Streck
Hematology · 57d
Cleared Aug 08, 2005
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100...
K051199 · GKZ
Sysmex America, Inc.
Hematology · 90d
Cleared Aug 05, 2005
VERIFYNOW-P2Y12 ASSAY
K051231 · JOZ
Accumetrics, Inc.
Hematology · 84d