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
769–792 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP
Kamiya Biomedical Co.
Hematology · 239d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · GJS
Lifescan, Inc.
Hematology · 347d
Cleared May 11, 2001
R & D 4K RETIC
K010470 · JPK
R&D Systems, Inc.
Hematology · 80d
Cleared May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · JPA
Dade Behring, Inc.
Hematology · 70d
Cleared Apr 13, 2001
IL TEST FREE PROTEIN S
K010379 · GGP
Instrumentation Laboratory CO
Hematology · 64d
Cleared Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
K010765 · GKZ
Beckman Coulter, Inc.
Hematology · 30d
Cleared Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
K010324 · GGN
Diagnostica Stago, Inc.
Hematology · 66d
Cleared Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · GGN
Diagnostica Stago, Inc.
Hematology · 63d
Cleared Apr 03, 2001
ADVIA RETIC PLUS
K010461 · JPK
R&D Systems, Inc.
Hematology · 46d
Cleared Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · JPK
Quantimetrix Corp.
Hematology · 23d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO
Sigma Diagnostics, Inc.
Hematology · 64d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · DAP
Roche Diagnostics Corp.
Hematology · 198d
Cleared Mar 16, 2001
CBC-SF
K010409 · JPK
R&D Systems, Inc.
Hematology · 32d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301 · JOY
CellaVision AB
Hematology · 146d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328 · GIZ
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · GGC
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Feb 23, 2001
EASE-A-CULT
K002756 · KHE
Diagnostica, Inc.
Hematology · 171d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Dade Behring, Inc.
Hematology · 67d
Cleared Feb 12, 2001
ASSERACHROM HPIA TEST KIT
K003767 · LCO
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 05, 2001
MINIQUANT D-DIMER, MODEL 1447
K002642 · DAP
Biopool Intl., Inc.
Hematology · 165d
Cleared Feb 05, 2001
ADVIA 120 HEMATOLOGY
K003796 · GKZ
Bayer Corp.
Hematology · 59d