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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode MTG PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Dimension® FPSA Flex® reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S039 12/20/2021
ARCHITECT Free PSA / Alinity i Free PSA Abbott Laboratories P980007 S046 12/15/2021
ARCHITECT Free PSA (LN 6C07) Abbott Laboratories P980007 S045 12/06/2021
Dimension Vista FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S037 10/08/2021
IMMULITE / IMMULITE 1000 FREE PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S013 04/28/2021
Atellica IM Prostate-Specific Antigen (PSA) Assay SIEMENS HEALTHCARE DIAGNOSTICS P950021 S024 04/27/2021
ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA... Abbott Laboratories P980007 S044 04/22/2021
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