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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 NumberS021
Date Received09/13/1994
Decision Date10/04/1994
Reclassified Date 05/06/2003
Product Code LON 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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