VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Streptococcus Inducible Clindamycin Resistance.

Pre-market Notification Details

Device IDK111909
510k NumberK111909
Device Name:VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNathan Hardesty
CorrespondentNathan Hardesty
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-05
Decision Date2011-10-18
Summary:summary

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