BIOMERIEUX HEMOLAB COFAC X

Plasma, Coagulation Factor Deficient

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Biomerieux Hemolab Cofac X.

Pre-market Notification Details

Device IDK935851
510k NumberK935851
Device Name:BIOMERIEUX HEMOLAB COFAC X
ClassificationPlasma, Coagulation Factor Deficient
Applicant BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
ContactCheryl Winters-heard
CorrespondentCheryl Winters-heard
BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-08
Decision Date1995-01-17

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