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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.
 
DeviceMICROSCAN RAPID FLUOROGENIC PANELS
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantDADE INTL., INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,, CA 95691
PMA NumberP870049
Supplement NumberS024
Date Received08/01/1995
Decision Date03/12/1996
Reclassified Date 05/06/2003
Product Code LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR OFLOXACIN TO BE ADDED TOTHE GRAM-NEGATIVE RAPID FLUOROGENIC PANELS AT THE EQUIVALENCY CONCENTRATIONS OF 0.25 UG/ML TO 16 UG/ML
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