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. |
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Device | ARCHITECT FREE PSA ASSAY |
Generic Name | Test, 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 Number | P980007 |
Supplement Number | S010 |
Date Received | 04/02/2010 |
Decision Date | 08/31/2010 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-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 FREE PSA ASSAY. |
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