RAPI/TEX ASO STANDARD SERUM

Antistreptolysin - Titer/streptolysin O Reagent

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rapi/tex Aso Standard Serum.

Pre-market Notification Details

Device IDK800642
510k NumberK800642
Device Name:RAPI/TEX ASO STANDARD SERUM
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant CALBIOCHEM-BEHRING CORP. 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 Received1980-03-24
Decision Date1980-04-24

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