ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 Ug/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 Piperacillin/tazobactam (p/t) (0.016/4-256/4 Ug/ml).

Pre-market Notification Details

• Device ID: K190154
• 510k Number: K190154
• Device Name: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 Ug/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: 2019-01-30
• Decision Date: 2019-05-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03573026555832	K190154	000
03573026618742	K190154	000