BI-ASO SLIDE TEST

Antistreptolysin - Titer/streptolysin O Reagent

BIOLOGICS INTL., INC.

The following data is part of a premarket notification filed by Biologics Intl., Inc. with the FDA for Bi-aso Slide Test.

Pre-market Notification Details

Device IDK812060
510k NumberK812060
Device Name:BI-ASO SLIDE TEST
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant BIOLOGICS INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-21
Decision Date1981-08-13

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