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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(R)
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870049
Supplement NumberS013
Date Received06/28/1991
Decision Date11/06/1991
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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