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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
glyn rhonwy, llanberis
gwynedd ll55 4el LL554
PMA NumberP930027
Supplement NumberS008
Date Received12/16/2008
Decision Date02/25/2010
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR IMMULITE 1000/2000/2500 PSA AND IMMULITE 1000/2000/2500 THIRD GENERATION PSA TO ADD AN ADDITIONAL ANTIBODY (MURINE MONOCLONAL ANTIBODY CONJUGATE: MAB 7F4), INCLUDE A PH TREATMENT TO THE CHICKEN SERUM AND REMOVAL OF THIMERASOL AS A PRESERVATIVE.
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