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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 NameSIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP930027
Supplement NumberS008
Date Received12/18/2008
Decision Date02/25/2010
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for immulite 1000/2000/2500 psa and immulite 1000/2000/2500 third generation psa to add an additional antibody (murine monoclonal antibody conjugate: mab 7f4), include a ph treatment to the chicken serum and removal of thimerasol as a preservative.
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