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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.
 
DeviceMICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
DADE INTL., INC.
1584 enterprise blvd.
west sacramento,, CA 95691
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/material
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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