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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 NameMONOPREP PAP TEST
Classification Nameprocessor, cervical cytology slide, automated
Generic Namekit,cervical smear
ApplicantMONOGEN, INC.
PMA NumberP040052
Supplement NumberS007
Date Received09/04/2008
Decision Date10/01/2008
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of vendor to pharmco-aaper for the alcohol-based specimen transport solution (mppt-sts) that preserves specimen cellular morphology and inhibits microbial growth.
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