ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

Manual Antimicrobial Susceptibility Test Systems

BIOMERIEUX SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Telavancin In 0.002-32 Ug/ml And 0.016-256 Ug/ml.

Pre-market Notification Details

Device IDK102535
510k NumberK102535
Device Name:ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne,  FR 69290
ContactAsa Karlsson
CorrespondentAsa Karlsson
BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne,  FR 69290
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-03
Decision Date2011-05-16

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