CORD, ENTEROBACTERIACEAE BIOCHEMICAL

Kit, Identification, Enterobacteriaceae

VITEK SYSTEMS, INC.

The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Cord, Enterobacteriaceae Biochemical.

Pre-market Notification Details

Device IDK782056
510k NumberK782056
Device Name:CORD, ENTEROBACTERIACEAE BIOCHEMICAL
ClassificationKit, Identification, Enterobacteriaceae
Applicant VITEK SYSTEMS, 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 Received1978-12-11
Decision Date1979-01-26

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