STREP-SPEC

Kit, Identification, Enterobacteriaceae

MICRO-MEDIA SYSTEMS, INC.

The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Strep-spec.

Pre-market Notification Details

Device IDK791991
510k NumberK791991
Device Name:STREP-SPEC
ClassificationKit, Identification, Enterobacteriaceae
Applicant MICRO-MEDIA 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 Received1979-10-03
Decision Date1979-11-13

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