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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 Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
ApplicantDADE BEHRING, INC.
PMA NumberP000021
Supplement NumberS004
Date Received11/15/2004
Decision Date12/02/2004
Product Code
LTJ[ Registered Establishments with LTJ ]
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 of the dimension tpsa flex reagent cartridge on the dimension xpand plus analyzer.
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