ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

Manual Antimicrobial Susceptibility Test Systems

BioMerieux SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Delafloxacin (dfx) (0.002-32 µg/ml).

Pre-market Notification Details

• Device ID: K192738
• 510k Number: K192738
• Device Name: ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
• Classification: Manual Antimicrobial Susceptibility Test Systems
• Applicant: BioMerieux SA 376, Chemin De L'Orme Marcy L'etoile, FR 69280
• Contact: Sophie Quiblier
• Correspondent: Sophie Quiblier; BioMerieux SA 376, Chemin De L'Orme Marcy L'etoile, FR 69280
• Product Code: JWY
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-27
• Decision Date: 2019-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03573026563165	K192738	000