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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 NumberS025
Date Received03/06/2012
Decision Date03/22/2012
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an absorbance test to confirm abbott¿s claim of 70% detergent (triton x-405) concentration to verify conformance of incoming product.
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