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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 NameADVIA CENTAUR CPSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameimmunoassay for the quantitative measurement of complexed prostate-specific antigen (cpsa) in human serum
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP990055
Supplement NumberS013
Date Received08/06/2010
Decision Date08/30/2010
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an automated process for making a component that is common to the psa and cpsa assays.
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