VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Antimircrobial Susceptibility Test System For Levofloxacin.

Pre-market Notification Details

• Device ID: K020871
• 510k Number: K020871
• Device Name: VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
• Classification: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
• Applicant: BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320
• Contact: Nancy Weaver
• Correspondent: Nancy Weaver; BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320
• Product Code: LON
• CFR Regulation Number: 866.1645 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-28
• Decision Date: 2002-03-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03573026427382	K020871	000
03573026245573	K020871	000