STAGO FACTOR XI-DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Stago Factor Xi-deficient Plasma.

Pre-market Notification Details

Device IDK933444
510k NumberK933444
Device Name:STAGO FACTOR XI-DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
ContactAndrew Loc B. Le
CorrespondentAndrew Loc B. Le
AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-14
Decision Date1993-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
13607450007234 K933444 000

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