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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 NameTHINPREP 2000 SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS004
Date Received10/02/1996
Decision Date10/08/1997
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of preservcyt solution as an alternative collection and transport medium for gynecologic specimens tested with the digene hybrid capture system hpv dna assay.
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