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
265–288 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · GKZ
Siemens Healthcare Diagnostics
Hematology · 435d
Cleared Nov 16, 2011
THE BELMONT BUDDY LITE FLUID WARMER
K112639 · BSB
Belmont Instrument Corp.
Hematology · 65d
Cleared Oct 26, 2011
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY...
K111822 · KFF
Diagnostica Stago, Inc.
Hematology · 120d
Cleared Oct 20, 2011
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
K110432 · GGN
Affinity Biologicals, Inc.
Hematology · 247d
Cleared Sep 16, 2011
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
K102778 · JOY
CellaVision AB
Hematology · 357d
Cleared Sep 14, 2011
FOB ONE STEP RAPID TEST
K110309 · KHE
Orient Gene Biotech
Hematology · 224d
Cleared Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031 · GIR
Instrumentation Laboratory CO
Hematology · 231d
Cleared Aug 10, 2011
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K101533 · JPA
Tem Innovations GmbH
Hematology · 433d
Cleared Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · GJT
Instrumentation Laboratory CO
Hematology · 163d
Cleared Jun 23, 2011
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K100716 · GGN
Aalto Scientific, Ltd.
Hematology · 468d
Cleared Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · JOX
Medtronic, Inc.
Hematology · 27d
Cleared May 26, 2011
CELL-CHEX WITH CPPD CRYSTALS
K110718 · GLQ
Streck
Hematology · 72d
Cleared May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
K110303 · DAP
Siemens Healthcare Diagnostics
Hematology · 104d
Cleared Apr 28, 2011
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K101578 · JPK
R&D Systems, Inc.
Hematology · 325d
Cleared Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
K102552 · GGC
Instrumentation Laboratory CO
Hematology · 210d
Cleared Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
K102164 · GGP
Instrumentation Laboratory CO
Hematology · 227d
Cleared Mar 07, 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
K102064 · GKZ
Becton, Dickinson & CO
Hematology · 227d
Cleared Mar 04, 2011
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K110393 · GKR
Ekf Diagnostic GmbH
Hematology · 21d
Cleared Jan 28, 2011
HEMA SCREEN ER
K102664 · KHE
Immunostics Inc.,
Hematology · 135d
Cleared Dec 30, 2010
LUPOTEK KCT
K090105 · GGW
R2 Diagnostics, Inc.
Hematology · 714d
Cleared Dec 21, 2010
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
K100790 · JPK
Beckman Coulter, Inc.
Hematology · 274d
Cleared Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · GGN
Dade Behring, Inc.
Hematology · 369d
Cleared Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
K100103 · GGC
Helena Laboratories
Hematology · 336d
Cleared Dec 06, 2010
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340 · JQC
Harvest Technologies, Corp.
Hematology · 21d