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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 GRAM NEGATIVE AST FOR AMIKACIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS094
Date Received07/22/1999
Decision Date10/07/1999
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic amikacin at concentrations of 8, 16 and 64 ug/ml to the vitek(r) 2 gram negative susceptibility test system. The device is indicated for use in vitek(r) 2 gram negative susceptibility test cards for the susceptibility testing of gram negative isolates to amikacin in the range of <2 to >64 ug/ml.
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