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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.
 
DeviceDIMENSION FPSA FLEX REAGENT CARTRIDGE
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE, P O BOX 6101
M/S 514
NEWARK, DE 19714-6101
PMA NumberP020027
Supplement NumberS014
Date Received10/18/2010
Decision Date12/13/2010
Product Code MTG 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REMOVE THE REAGENT MANAGEMENT SYSTEM FROM THE DIMENSION EXL WITH LM SYSTEM. THE CONFIGURATION WILL BE CALLED THE DIMENSION EXL 200 SYSTEM.
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