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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITEK 2 SYSTEM
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD, MO 63042-2395
PMA NumberN50510
Supplement NumberS082
Date Received07/01/1998
Decision Date06/16/1999
Reclassified Date 12/28/2001
Product Code LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for major modifications to the design of the device in order to automate manual operations and enhance its 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 aerobic gram negative bacilli when tested on a Gram Negative Susceptibility Test Card.
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