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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(R) 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 NumberS030
Date Received05/17/2000
Decision Date06/05/2000
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 CHANGE THAT ADDS A CONTRAINDICATION TO THE GRAM NEGATIVE MICROSCAN RAPID FLUOROGENIC PANELS OF "DO NOT REPORT" WHEN TESTING ALL GRAM NEGATIVE ORGANISMS WITH CEFOPERAZONE USING EITHER THE MIC OR BREAKPOINT FORMATS.
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