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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode MTG PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S044 12/16/2020
ARCHITECT Free PSA and Alinity i Free PSA Abbott Laboratories P980007 S043 11/05/2020
ADVIA Centaur PSA Readypack Reagents SIEMENS HEALTHCARE DIAGNOSTICS P950021 S023 10/27/2020
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S043 10/16/2020
Dimension Vista FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S038 10/13/2020
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S042 10/07/2020
IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULI... SIEMENS MEDICAL SOLUTIONS DIAG P060005 S012 09/08/2020
IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S011 08/18/2020
Advia Centaur PSA Immunoassay and Atellica IM PSA ... SIEMENS HEALTHCARE DIAGNOSTICS P950021 S019 07/02/2020
Alinity i Free PSA assay Abbott Laboratories P980007 S041 06/05/2020
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