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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 NameAXSYM FREE PSA & ARCHITECT FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namefree psa
ApplicantABBOTT LABORATORIES
PMA NumberP980007
Supplement NumberS022
Date Received09/07/2011
Decision Date09/13/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of a bsa screening test to identify protease contamination in vendor lots of incoming bsa prior to purchase.
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