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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 15 of 15 Results
productcode MTF PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Elecsys total PSA ROCHE DIAGNOSTICS CORP. P990056 S037 05/12/2020
ARCHITECT Total PSA Reagent/Calibrator/Control Kit Abbott Laboratories P910007 S052 04/10/2020
Atellica IM Prostate-Specific Antigen (PSA) Assay SIEMENS HEALTHCARE DIAGNOSTICS P950021 S021 04/03/2020
ADVIA Centaur and Atellica IM PSA SIEMENS HEALTHCARE DIAGNOSTICS P950021 S020 03/19/2020
Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S053 03/17/2020
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