SYSTEK #1 EIKEN

Kit, Identification, Enterobacteriaceae

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Systek #1 Eiken.

Pre-market Notification Details

Device IDK813164
510k NumberK813164
Device Name:SYSTEK #1 EIKEN
ClassificationKit, Identification, Enterobacteriaceae
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSS  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-10
Decision Date1981-12-31

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