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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/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA
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 NumberS006
Date Received08/16/2011
Decision Date09/12/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Permanent implementation of the incoming specification for zinc content for 2-amino-2-methyl-1- propanol (amp) buffer and elimination of substrate verification testing.
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