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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
BD Diagnostic Systems
4025 stirrup creek drive
suite 400
durham, NC 27703
PMA NumberP970018
Supplement NumberS027
Date Received09/30/2013
Decision Date10/16/2013
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the bd prepstain¿ system.