MODIFIED FOX EXTRA GRAM POSITIVE

Manual Antimicrobial Susceptibility Test Systems

MICRO-MEDIA SYSTEMS, INC.

The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Modified Fox Extra Gram Positive.

Pre-market Notification Details

Device IDK945997
510k NumberK945997
Device Name:MODIFIED FOX EXTRA GRAM POSITIVE
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant MICRO-MEDIA SYSTEMS, INC. 7194 OAKLAND MILLS RD. Columbia,  MD  21045
ContactMaryalice Francisco
CorrespondentMaryalice Francisco
MICRO-MEDIA SYSTEMS, INC. 7194 OAKLAND MILLS RD. Columbia,  MD  21045
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-07
Decision Date1995-02-16

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