PMA N50510

Device: VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S146
Product code: LTW
Decision date: 2001-10-17
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD AN INSTRUCTION TO THE VITEK 2 USER'S MANUAL WHICH DESCRIBES ADDITIONAL VISUAL OBSERVATION STEPS TO THE PROCEDURE FOR THE INSTALLATION OF THE VITEK 2 ACCESSORY KIT AND SALINE BAG.

Current openFDA PMA Record#

Device: VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S146
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2001-10-17
Decision code: APPR
Date received: 2001-09-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD AN INSTRUCTION TO THE VITEK 2 USER'S MANUAL WHICH DESCRIBES ADDITIONAL VISUAL OBSERVATION STEPS TO THE PROCEDURE FOR THE INSTALLATION OF THE VITEK 2 ACCESSORY KIT AND SALINE BAG.