SERIMM SURE ASO-CHEK CONTROL SERUM

Antistreptolysin - Titer/streptolysin O Reagent

ANALYTICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Serimm Sure Aso-chek Control Serum.

Pre-market Notification Details

Device IDK842839
510k NumberK842839
Device Name:SERIMM SURE ASO-CHEK CONTROL SERUM
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant ANALYTICAL PRODUCTS, 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 Received1984-07-20
Decision Date1984-08-23

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