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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 NamePSA IMMULITE ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP930027
Supplement NumberS012
Date Received08/08/2011
Decision Date09/07/2011
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 
The change is to implement use of a fully automated filling and packaging line for the immulite chemiluminescent substrate. The current method of filling and packaging the substrate is by use of a semi-automated line. Full automation of the line eliminates repetitive actions that are performed manually.
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