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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 NameIMMULITE FPSA ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,psa,free(non complexed)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP060005
Supplement NumberS008
Date Received05/30/2012
Decision Date11/08/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for eliminating the test redundancy by using only the biorad lyphocheck immunoassay plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of immulite afp, free psa, and psa/3rd generation psa assay performance.
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