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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.
 
DevicePAPNET (R) TESTING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBD DIAGNOSTICS
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP940029
Date Received09/21/1994
Decision Date11/08/1995
Withdrawal Date 06/04/2009
Product Code MNM 
Docket Number 96M-0472
Notice Date 12/11/1996
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PAPNET TESTING SYSTEM
Supplements:  S001 S002 S003 
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