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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 4 of 4 Results
productcode MTG PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PMA
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Decision
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Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S045 12/16/2022
IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2... SIEMENS MEDICAL SOLUTIONS DIAG P060005 S016 10/14/2022
ARCHITECT Free PSA / Alinity i Free PSA Abbott Laboratories P980007 S047 10/12/2022
Atellica® IM Prostate-Specific Antigen (PSA) Assay SIEMENS HEALTHCARE DIAGNOSTICS P950021 S025 03/29/2022
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