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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 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
ApplicantDADE BEHRING, INC.
PMA NumberP020027
Supplement NumberS003
Date Received04/01/2005
Decision Date06/02/2005
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the streamlab analytical workcell and sample transfer module to the dimension rxl max.
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