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 | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P970038 |
Supplement Number | S043 |
Date Received | 07/22/2020 |
Decision Date | 10/16/2020 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to implement a new resin blend for the UniCel DxI Wash Buffer II Cubitainer. |
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