510(k) K192050— ETEST Eravacycline (ERV) (0.002 32 µg/mL)

Substantially Equivalent

Biomerieux S.A.

Clearance details

Applicant: Biomerieux S.A.
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2019-07-31
Decision date: 2019-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy L'Etoile, FR

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