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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 NameARCHITECT FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namefree psa
ApplicantABBOTT LABORATORIES
PMA NumberP980007
Supplement NumberS015
Date Received12/22/2010
Decision Date01/13/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a quality control test for an incoming raw material for the architect pre-trigger solution.
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