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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
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS086
Date Received03/16/1999
Decision Date06/24/1999
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software revisions for major modifications to the design of the device in order to automate manual operations and enhance performance. The device as modified will be marketed under the trade name vitek(r) 2 system and is intended as a laboratory aid in the determination of the in vitro susceptibility of bacteria when tested on a gram negative susceptibility test card or a gram positive susceptibility test card containing antimicrobial agents at selected concentrations.
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