ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)— 510(k) K190154

Clearance details

Applicant

Biomerieux S.A.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2019-01-30

Decision date

2019-05-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marcy-L'Etoile, FR

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