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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.
 
DeviceIMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
GLYN RHONWY, LLANBERIS
GWYNEDD LL55 4EL LL554
PMA NumberP930027
Supplement NumberS005
Date Received01/21/2003
Decision Date02/28/2003
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE IMMULITE 1000 ANALYZER TO THE ANALYZERS USED FOR THE IMMULITE PSA AND IMMULITE THIRD GENERATION PSA ASSAYS.
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