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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 NameDIMENSION TPSA FLEX REAGENT CARTRIDGE
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP000021
Supplement NumberS019
Date Received10/18/2010
Decision Date12/13/2010
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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