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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 Nameprostate specific antigen assay (psa)
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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