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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 NumberS027
Date Received06/09/1998
Decision Date06/30/1998
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 the addition of a limitation to use an alternative method to confirm results for the testing of Staphylococcus spp. with the antibiotic Vancomycin. The device, as modified, will be marketed under the trade name MicroScan(R) Rapid Fluorogenic.
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