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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 GRAM NEGATIVE AST FOR TOBRAMYCIN
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS090
Date Received07/02/1999
Decision Date09/17/1999
Reclassified Date12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the antibiotic tobramycin to the Vitek(R) 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek(R) 2 and is indicated for use in the Vitek(R) 2 gram negative susceptibility panel for the susceptibility testing of gram negative isolates to tobramycin in the range of <1 to >16 ug/ml.
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