VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE

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 Ast- Gram Postive Penicillin For Streptococcus Pneumoniae.

Pre-market Notification Details

Device IDK113783
510k NumberK113783
Device Name:VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
ContactElizabeth Landon
CorrespondentElizabeth Landon
BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-22
Decision Date2012-08-07
Summary:summary

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