STREPTACOCCUS CO-AGGLUTINATION KIT

Exoenzymes, Multiple, Streptococcal

AMERICAN SCIENTIFIC PRODUCTS

The following data is part of a premarket notification filed by American Scientific Products with the FDA for Streptacoccus Co-agglutination Kit.

Pre-market Notification Details

Device IDK822799
510k NumberK822799
Device Name:STREPTACOCCUS CO-AGGLUTINATION KIT
ClassificationExoenzymes, Multiple, Streptococcal
Applicant AMERICAN SCIENTIFIC PRODUCTS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGTP  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-16
Decision Date1982-12-19

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