SLIDE CULTURE U 'EIKEN'

Kit, Screening, Urine

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Slide Culture U 'eiken'.

Pre-market Notification Details

Device IDK861631
510k NumberK861631
Device Name:SLIDE CULTURE U 'EIKEN'
ClassificationKit, Screening, Urine
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 CodeJXA  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-29
Decision Date1986-06-10

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