ASO QUANTUM, ANTISTREPTOLYSIN O TEST

Antistreptolysin - Titer/streptolysin O Reagent

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Aso Quantum, Antistreptolysin O Test.

Pre-market Notification Details

Device IDK801177
510k NumberK801177
Device Name:ASO QUANTUM, ANTISTREPTOLYSIN O TEST
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant SCLAVO, 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 Received1980-05-16
Decision Date1980-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.