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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 15 Results
productcode MTF PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S056 12/16/2020
ARCHITECT Total PSA and Alinity i Total PSA Abbott Laboratories P910007 S054 11/05/2020
Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S055 10/16/2020
Dimension Vista TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S043 10/13/2020
Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S054 10/07/2020
IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULI... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S024 09/08/2020
ADVIA Centaur PSA Readypack Reagents SIEMENS HEALTHCARE DIAGNOSTICS P950021 S022 08/25/2020
IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S023 08/18/2020
Alinity i Total PSA Assay Abbott Laboratories P910007 S051 08/07/2020
ARCHITECT Total PSA Abbott Laboratories P910007 S053 05/23/2020
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