PROTEIN C REAGENT, COAGULOMETRIC

Test, Qualitative And Quantitative Factor Deficiency

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Protein C Reagent, Coagulometric.

Pre-market Notification Details

Device IDK924425
510k NumberK924425
Device Name:PROTEIN C REAGENT, COAGULOMETRIC
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactLori Baranauskas
CorrespondentLori Baranauskas
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-01
Decision Date1995-01-24

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