ETEST Eravacycline (ERV) (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 Eravacycline (erv) (0.002 – 32 µg/ml).

Pre-market Notification Details

• Device ID: K192050
• 510k Number: K192050
• Device Name: ETEST Eravacycline (ERV) (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: Marine Taravant
• Correspondent: Marine Taravant; 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: 2019-07-31
• Decision Date: 2019-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03573026560997	K192050	000