ASO SLIDE EIKEN

Antistreptolysin - Titer/streptolysin O Reagent

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Aso Slide Eiken.

Pre-market Notification Details

Device IDK853276
510k NumberK853276
Device Name:ASO SLIDE EIKEN
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
ContactJames F Godfrey
CorrespondentJames F Godfrey
SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
Product CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-05
Decision Date1985-08-20

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