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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode MZP PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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PMA
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Decision
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COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 Roche Molecular Systems, Inc. P060030 S086 08/11/2021
cobas HCV Roche Molecular Systems, Inc. P150015 S043 06/02/2021
Alinity m HCV Abbott Molecular, Inc. P190025 S006 06/01/2021
Alinity m HCV Abbott Molecular, Inc. P190025 S004 04/26/2021
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 Roche Molecular Systems, Inc. P060030 S085 03/09/2021
Abbott RealTime HCV ABBOTT MOLECULAR, INC. P100017 S024 03/05/2021
Alinity m HCV Abbott Molecular, Inc. P190025 S005 03/05/2021
Alinity m HCV Abbott Molecular, Inc. P190025 S003 01/19/2021
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