CHROMID MRSA AGAR, MODEL: REF 43 841

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Chromid Mrsa Agar, Model: Ref 43 841.

Pre-market Notification Details

Device IDK091024
510k NumberK091024
Device Name:CHROMID MRSA AGAR, MODEL: REF 43 841
ClassificationCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNancy Weaver
CorrespondentNancy Weaver
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeJSO  
CFR Regulation Number866.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-10
Decision Date2009-07-17
Summary:summary

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