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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 NumberS006
Date Received01/18/2008
Decision Date07/09/2008
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes based on the analysis of data from the post-market study entitled sure (specimen unsat rate evaluation). These changes have been incorporated into the laboratory information and instructions labeling.
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