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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 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP930027
Supplement NumberS013
Date Received08/16/2011
Decision Date09/12/2011
Product Code
MTF[ Registered Establishments with MTF ]
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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