ETEST Telavancin (TLA) (0.002-32 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 (tla) (0.002-32 Ug/ml).

Pre-market Notification Details

Device IDK180936
510k NumberK180936
Device Name:ETEST Telavancin (TLA) (0.002-32 Ug/mL)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile,  FR 69280
ContactAsa Karlsson
CorrespondentAsa Karlsson
bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile,  FR 69280
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-10
Decision Date2018-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026475352 K180936 000

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