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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.
 
Trade NamePREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantBD DIAGNOSTIC SYSTEMS
PMA NumberP970018
Supplement NumberS015
Date Received05/27/2009
Decision Date07/24/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the changes made to the prepstain software program in response to recall z-1090-2009.
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