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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMICROSCAN RAPID PANELS
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantDADE INTL., INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,, CA 95691
PMA NumberP870049
Date Received08/20/1987
Decision Date02/24/1988
Reclassified Date 05/06/2003
Product Code LON 
Docket Number 88M-0083
Notice Date 04/11/1988
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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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