ETEST Telavancin (TLA) (0.002-32 ug/mL)— 510(k) K180936

Clearance details

Applicant

Biomerieux S.A.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2018-04-10

Decision date

2018-07-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marcy-L'Etoile, FR

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