|Trade Name||THINPREP 2000 SYSTEM|
|Classification Name||processor, cervical cytology slide, automated|
|Generic Name||cytology slide preparation device|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for additional claims to the current approved labeling for thinprep 2000 system regarding removal of a 4 ml aliquot from the preservcyt vial prior to preparation of the thinprep pap test(tppt). This aliquot is only to be used to support performance of ancillary tests approved by the fda on preservcyt material.