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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 & IMMULITE 2000 FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,psa,free(non complexed)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP060005
Supplement NumberS003
Date Received11/02/2009
Decision Date01/21/2010
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at siemens healthcare diagnostics in newark, delaware.
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