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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 NameADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP950021
Date Received06/27/1995
Decision Date12/22/1995
Product Code
MTG[ Registered Establishments with MTG ]
Docket Number 96M-0200
Notice Date 07/15/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the technicon immuno 1 psa assay - this device is an in vitro diagnostic device.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 
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