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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 NameAUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
ApplicantBD DIAGNOSTICS
PMA NumberP950009
Date Received02/24/1995
Decision Date09/29/1995
Product Code
MNM[ Registered Establishments with MNM ]
Docket Number 96M-0332
Notice Date 09/23/1996
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the autopap 300 qc system.
Supplements: S001 S002 S003 S004 S005 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 
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