BI-RA SLIDE TEST

System, Test, Rheumatoid Factor

BIOLOGICS INTL., INC.

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

Pre-market Notification Details

Device IDK811375
510k NumberK811375
Device Name:BI-RA SLIDE TEST
ClassificationSystem, Test, Rheumatoid Factor
Applicant BIOLOGICS INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-15
Decision Date1981-06-12

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