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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMICROSCAN RAPID PANELS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptibility system
Regulation Number866.1645
ApplicantDADE INTL., INC.
PMA NumberP870049
Date Received08/20/1987
Decision Date02/24/1988
Reclassified Date 05/06/2003
Product Code
LON[ Registered Establishments with LON ]
Docket Number 88M-0083
Notice Date 04/11/1988
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S018 S020 S021 S022 
S023 S024 S025 S027 S028 S029 S030 S031 S032 
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