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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 NumberS005
Date Received10/22/2007
Decision Date08/11/2008
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located in lincolnshire, illinois and waukegan, illinois.
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