STACHROM ANTIPLASMIN TEST KIT

Test, Qualitative And Quantitative Factor Deficiency

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Stachrom Antiplasmin Test Kit.

Pre-market Notification Details

Device IDK882602
510k NumberK882602
Device Name:STACHROM ANTIPLASMIN TEST KIT
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
ContactLoc B Le,phd
CorrespondentLoc B Le,phd
AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-24
Decision Date1988-09-02

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