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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device p2psa
Definition Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Product CodeOYA
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
0 0 0 0 0 2 2

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