Cleared Traditional

ETEST Eravacycline (ERV) (0.002 ? 32 ?g/mL)

K192050 · Biomerieux S.A. · Microbiology
Sep 2019
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K192050 is an FDA 510(k) clearance for the ETEST Eravacycline (ERV) (0.002 ? 32 ?g/mL), a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Biomerieux S.A. (Marcy L'Etoile, FR). The FDA issued a Cleared decision on September 27, 2019, 58 days after receiving the submission on July 31, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K192050 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2019
Decision Date September 27, 2019
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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