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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 NumberS001
Date Received08/08/2000
Decision Date08/29/2000
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the protocol for the autocyte prep post-approval study.
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