Cleared Traditional

ETEST Delafloxacin (DFX) (0.002-32 ?g/mL)

K192738 · Biomerieux S.A. · Microbiology
Nov 2019
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K192738 is an FDA 510(k) clearance for the ETEST Delafloxacin (DFX) (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'?toile, FR). The FDA issued a Cleared decision on November 26, 2019, 60 days after receiving the submission on September 27, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K192738 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2019
Decision Date November 26, 2019
Days to Decision 60 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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