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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 SUBSTRATE REAGENT
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa test kit
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP930027
Supplement NumberS014
Date Received12/19/2011
Decision Date04/05/2012
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to remove the slip agent from the bottle used to package the immulite substrate.
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