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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 NameFPSA IMMULITE 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 NumberS005
Date Received08/08/2011
Decision Date09/07/2011
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 
The change is to implement use of a fully automated filling and packaging line for the immulite chemilusminescent 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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