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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.
 
DeviceARCHITECT FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
Abbott Laboratories
100 abbott park rd.
ap5n-2 dept 09vb
abbott park, IL 60064-6070
PMA NumberP980007
Supplement NumberS030
Date Received02/11/2013
Decision Date03/13/2013
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change an in-process quality control test method to continue production of the anti-hbs negative human plasmas used in the manufacture of the architect assays.
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