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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.
 
DeviceABBOTT ARCHITECT TOTAL PSA ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
Abbott Laboratories
100 abbott park rd.
abbott park, IL 60064-3500
PMA NumberP910007
Supplement NumberS018
Date Received04/02/2010
Decision Date08/31/2010
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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 TOTAL PSA ASSAY.
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