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KQJ — System, Fibrinogen Determination Class II

FDA Device Classification

Classification Details

Product Code
KQJ
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
K251968instrumentation laboratory (il)HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLJuly 24, 2025
K073367instrumentation laboratoryHEMOSIL FIBRINOGEN-CDecember 27, 2007
K050928dade behringDADE THROMBIN REAGENTJune 29, 2005
K971858sigma diagnosticsSIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)October 9, 1997
K970189panbioFIF TMMay 21, 1997
K965113crestat diagnosticsN-ASSAY TIA FIBRINOGEN TEST KITApril 16, 1997
K934326behring diagnosticsMULTIFIBREN UApril 19, 1994
K931721instrumentation laboratoryIL TEST FIBRINOGEN-CAugust 13, 1993
K922416binding siteFIBRINOGEN RID TEST KITMarch 9, 1993
K925988behring diagnosticsMULTIFIBRENMarch 1, 1993
K923593international technidyneHEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLASSeptember 22, 1992
K920258bd becton dickinson vacutainer systems preanalyticQBC FIBRINOGENJune 26, 1992
K900939incstarSPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)May 16, 1990
K900895organon teknikaCOAG-A-MATE - RA4April 16, 1990
K896052medical diagnostic technologiesFIBRINOGEN ASSAY KITNovember 9, 1989
K884179unipathTURBOX FIBRINOGENDecember 20, 1988
K841366diatechDIA FIBRINJune 1, 1984
K841020helena laboratoriesFIBRINOGEN ASSAY KITMay 2, 1984
K840211wellcome diagnosticsFIBRI-PREST AUTOMATE HA34March 2, 1984
K834571diatechFIBRINOGEN TESTFebruary 4, 1984