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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.
 
DeviceAUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBd Diagnostics
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP950009
Date Received02/24/1995
Decision Date09/29/1995
Product Code MNM 
Docket Number 96M-0332
Notice Date 09/23/1996
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE AUTOPAP 300 QC SYSTEM
Supplements: S001 S002  S013 S016 S010 S004 S003 S008 S021 S015 S018 
S017 S019 S005 S012 S009 S011 S020 S023 S022 S026 S025 S024 
S014 
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