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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 NumberS084
Date Received08/18/1998
Decision Date06/28/1999
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 the addition of four antibiotics to the Gram Positive Susceptibility Card. 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 positive bacteria when tested on a Gram Positive Susceptibility Test Card with specific antimicrobial agents and concentrations.
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