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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 SYSTEMS "GENERAL SUSCEPTIBILITY CARD"
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
PMA NumberN50510
Supplement NumberS076
Date Received01/13/1997
Decision Date03/27/1997
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for levofloxacin to be included on the gram negative susceptibility card in three concentrations (equivalent to 1, 4 and 8 ug/ml).
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