SEROIDEN STREPTO KIT 'EIKEN'

Antisera, All Groups, Streptococcus Spp.

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Seroiden Strepto Kit 'eiken'.

Pre-market Notification Details

Device IDK861098
510k NumberK861098
Device Name:SEROIDEN STREPTO KIT 'EIKEN'
ClassificationAntisera, All Groups, Streptococcus Spp.
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 CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-24
Decision Date1986-08-12

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