Cleared Traditional

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

K191953 · Biomerieux S.A. · Microbiology
Aug 2019
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K191953 is an FDA 510(k) clearance for the ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL), a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Biomerieux S.A. (Marcy-L'?toile, FR). The FDA issued a Cleared decision on August 22, 2019, 31 days after receiving the submission on July 22, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K191953 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2019
Decision Date August 22, 2019
Days to Decision 31 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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