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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 NumberS004
Date Received07/27/2007
Decision Date08/31/2007
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of reflective white label stock (pn 12358) on all monoprep vials, including the monoprep pap test vial and the reprocessing vial.
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