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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 Total PSA Reagent/Calibrator/Control Kit
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP910007
Supplement NumberS052
Date Received01/22/2019
Decision Date04/10/2020
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to implement of new lot of ARCHITECT Total PSA Secondary Calibrators A through F.
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