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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
ApplicantMICROSCAN DIV. BAXTER HEALTHCARE CORP.
PMA NumberP870049
Supplement NumberS004
Date Received07/20/1989
Decision Date01/22/1990
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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