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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 NumberS031
Date Received10/12/2001
Decision Date11/09/2001
Reclassified Date05/06/2003
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO STRENGTHEN CONTRAINDICATIONS TO THE RAPID GRAM NEGATIVE PROCEDURAL MANUALS FOR BOTH MIC AND BREAKPOINT FORMATS, WHICH DESCRIBES A LIMITATION FOR PERFORMANCE CHARACTERISTICS FOR ESBL PRODUCING ORGANISMS AND A LIMITATION FOR THOSE ORGANISMS (E.G., ENTEROBACTER SPECIES) WHICH EXPRESS INDUCIBLE BETA-LACTAMASE ENZYMES.
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