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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP950021
Date Received06/27/1995
Decision Date12/22/1995
Product Code MTG 
Docket Number 96M-0200
Notice Date 07/15/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TECHNICON IMMUNO 1 PSA ASSAY - THIS DEVICE IS AN IN VITRO DIAGNOSTIC DEVICE
Supplements: S013  S009 S010 S014 S011 S006 S001 S002 S003 S007 S008 
S004 S005 S012 S020 S021 S022 S019 S025 S024 S015 S016 S017 
S023 S018 S027 
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