GRAM NEGATIVE BACTERIAL IDENTIF- PANELS

Discs, Strips And Reagents, Microorganism Differentiation

MICRO-MEDIA SYSTEMS, INC.

The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Gram Negative Bacterial Identif- Panels.

Pre-market Notification Details

Device IDK823738
510k NumberK823738
Device Name:GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant MICRO-MEDIA SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-13
Decision Date1983-01-07

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