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KFF — Assay, Heparin Class II

FDA Device Classification

Classification Details

Product Code
KFF
Device Class
Class II
Regulation Number
864.7525
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213464instrumentation laboratoryHemosIL Liquid Anti-XaOctober 4, 2022
K162540siemens healthcare diagnostics prodctsINNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) HepAugust 22, 2017
K111822diagnostica stagoSTA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM /October 26, 2011
K090209instrumentation laboratoryHEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSJune 2, 2009
K050367hyphen biomedBIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6May 24, 2006
K013305cardiovascular diagnosticsENOXAPARIN TEST CARDAugust 23, 2002
K013637american diagnosticaACTICHROME HEPARIN (ANTI-FIIA)April 16, 2002
K013318american diagnosticaACTICHROME HEPARIN (ANTI-FXA), MODEL 832March 8, 2002
K010455diagnostica-stagoROTACHROM HEPARIN AND STA -ROTACHROM HEPARINJune 7, 2001
K010193international technidyneHEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYSJune 6, 2001
K983178instrumentation laboratoryCOAMATIC HEPARINNovember 3, 1998
K980242instrumentation laboratoryIL TEST HEPARINMarch 19, 1998
K972209medical diagnostic technologiesSPECTROLYSE HEPARIN (ANTI-IIA)August 12, 1997
K965076organon teknikaMDA HEPARIN ANTI-X ASSAYMarch 18, 1997
K952667helena laboratoriesCHROM Z-HEPARIN, CAT. NO 5242February 14, 1996
K952514chromogenixCOACUTE HEPARINNovember 20, 1995
K943519american bioproductsHBPM/LMWH CONTROL KITSeptember 26, 1995
K943520american bioproductsHEPARIN CONTROL KITSeptember 26, 1995
K943514american bioproductsTHE HEPANORM HBPM/LMWH KITSeptember 26, 1995
K943515american bioproductsROTACHROM HEPARIN TEST KITAugust 31, 1995