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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 NumberS024
Date Received11/23/2011
Decision Date12/21/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the quality control testing of an incoming raw material used for manufacturing the device and it¿s finished accessory.
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