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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 MAQ PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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Device
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PMA
Number
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Decision
Date
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BD Onclarity™ HPV Assay BECTON, DICKINSON AND COMPANY P160037 S019 04/18/2024
cobas® HPV Roche Molecular Systems, Inc. P100020 S059 02/23/2024
Alinity m HR HPV Abbott Molecular, Inc P230003 S001 02/05/2024
Alinity m HR HPV Assay Abbott Molecular, Inc P230003 S002 01/20/2024
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