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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS146
Date Received09/17/2001
Decision Date10/17/2001
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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.
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