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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/12/1997
Decision Date06/17/1999
Product Code
MKQ[ Registered Establishments with MKQ ]
Docket Number 99M-2144
Notice Date 07/07/1999
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
This device is indicated as a liquid-based, thin-layer cell preparation process. The system produces slides that are intended as replacements for conventional gynecologic pap smears. Autocyte prep slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S012 S014 S015 S016 S017 S018 S019 S020 S021 
S023 S024 S025 S027 S028 S029 
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