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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 NameDIMENSIONS FPSA FLEX REAGENT CARTRIDGE
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nameprostate specific antigen (psa) for detection and management of prostate cancers
ApplicantSIEMENS CORP.
PMA NumberP020027
Supplement NumberS012
Date Received07/06/2010
Decision Date09/02/2010
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a clot check device to the dimension exl with lm system when used with the dimension fpsa flex reagent cartridge.
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