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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceARCHITECT FREE PSA ASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2 DEPT 09VB
ABBOTT PARK, IL 60064-6070
PMA NumberP980007
Supplement NumberS010
Date Received04/02/2010
Decision Date08/31/2010
Product Code MTG 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INCORPORATING ADDITIONAL SPECIFIC PERFORMANCE CHARACTERISTIC INFORMATION IN REFERENCE TO PRECISION, LIMIT OF BLANK (LOB), LIMIT OF DETECTION (LOD), LIMIT OF QUANTITATION (LOQ), LINEARITY AND MEASURING INTERVAL IN THE PRODUCT LABELING FOR THE ARCHITECT FREE PSA ASSAY.
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