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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 PSA FLEX REAGENT CARTRIDGE
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
ApplicantDADE BEHRING, INC.
PMA NumberP000021
Supplement NumberS001
Date Received07/12/2001
Decision Date07/31/2001
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the dimension(r) psa flex(r) reagent cartridge for use with the dimension(r) xpand(tm) system.
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