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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 NameMICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantDADE INTL., INC.
PMA NumberP870049
Supplement NumberS025
Date Received09/28/1995
Decision Date05/03/1996
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanded gentamicin dilutions at concentrations of 0. 12-4, 6, and 8ug/ml, the removal of the limitation for the testing of salmonella/shigella with gentamicin, and additional limitations for the testing of acinetobacter baumanii and stenotrophomonas maltophilia with gentamicin.
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