AT-III CALIBRATOR

Antithrombin Iii Quantitation

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for At-iii Calibrator.

Pre-market Notification Details

Device IDK944279
510k NumberK944279
Device Name:AT-III CALIBRATOR
ClassificationAntithrombin Iii Quantitation
Applicant AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany,  NJ  07054
ContactAndrew Loc B Le
CorrespondentAndrew Loc B Le
AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany,  NJ  07054
Product CodeJBQ  
CFR Regulation Number864.7060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-30
Decision Date1995-04-07

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