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GIS — Test, Fibrinogen Class II

FDA Device Classification

Classification Details

Product Code
GIS
Device Class
Class II
Regulation Number
864.7340
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K143470diazyme laboratoriesDiazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen January 31, 2016
K042919r2 diagnosticsFIBROTEK FIBNovember 29, 2004
K993482kamiya biomedicalK-ASSAY FIBRINOGENDecember 6, 1999
K963902ortho diagnostic systemsQUANTITATIVE FIBRINOGEN ASSAYNovember 29, 1996
K941001diagnostic specialtiesENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITAugust 30, 1994
K925494biomerieux vitekBIOMERIEUX HEMOLAB FIBRINOMATMay 18, 1993
K923921instrumentation laboratoryIL TEST PT FIBRINOGEN HSOctober 26, 1992
K913061sigma diagnosticsFIBRINOGEN DETERMINATION KITOctober 9, 1991
K910636panbioABS CADKITApril 29, 1991
K903874haemachemFIBRINOTEST(TM) - FIBRINOGEN ASSAYFebruary 14, 1991
K881685diatechFIBRINOGENTEST-OAugust 9, 1988
K881150bio/dataKINETIC FIBRINOGEN ASSAYMarch 28, 1988
K781880pacific hemostasisASSAY KIT, THROMBO-SCREENDecember 4, 1978