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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.
 
DeviceCOMPLEXED PSA MICROTITER ELISA
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameantigen(complexed),prostate specific,(cpsa)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, MA 02032-1516
PMA NumberP990055
Supplement NumberS003
Date Received09/20/2001
Decision Date03/13/2002
Product Code
NAF[ Registered Establishments with NAF ]
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 MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
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