Cleared Traditional

ETEST Fosfomycin (FO) (0.032-512 ?g/mL)

K210757 · Biomerieux S.A. · Microbiology
Nov 2021
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K210757 is an FDA 510(k) clearance for the ETEST Fosfomycin (FO) (0.032-512 ?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 November 12, 2021, 242 days after receiving the submission on March 15, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K210757 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date November 12, 2021
Days to Decision 242 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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