FDA 510(k) Applications for Medical Device Product Code "KQJ"
(System, Fibrinogen Determination)

FDA 510(k) Number Applicant Device Name Decision Date
K965113 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA FIBRINOGEN TEST KIT 04/16/1997
K050928 DADE BEHRING, INC. DADE THROMBIN REAGENT 06/29/2005
K073367 INSTRUMENTATION LABORATORY CO. HEMOSIL FIBRINOGEN-C 12/27/2007
K970189 PANBIO, INC. FIF TM 05/21/1997
K971858 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) 10/09/1997


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