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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMICROSCAN RAPID FLUOROGENIC PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870049
Supplement NumberS021
Date Received09/13/1994
Decision Date10/04/1994
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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