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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 NameAUTOCYTE PREP SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING
PMA NumberP970018
Supplement NumberS002
Date Received12/01/2000
Decision Date05/25/2001
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 the addition of the prepmate accessory (prepmate method), which automates the initial manual steps of the autocyte prep laboratory process. The prepmate automatically mixes and removes the specimen from the gyn preservative vials, and layers the specimen onto cytorich density reagent in a test tube, and for the addition of the manual method, in which, rather than using the autocyte prep system for cell suspension and slide staining, the cell suspension is manually layered onto the slide and stained by a laboratory technician.
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