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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 SUBSTRATE REAGENT
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 NumberS007
Date Received12/19/2011
Decision Date04/05/2012
Product Code
MTG[ Registered Establishments with MTG ]
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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