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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.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameimmunochemistry analyzer
PMA NumberP910007
Supplement NumberS048
Date Received02/24/2015
Decision Date03/26/2015
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the precursor code for bovine serum and human prostate specific antigen with equivalent materials for the manufacture of the architect free psa and total psa calibrators, controls, and secondary calibrators.