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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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PMA Number P140023 Decision Date To 04/30/2024
 
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Roche cobas® KRAS Mutation Test, Roche cobas® DNA ... Roche Molecular Systems, Inc. P140023 S026 08/17/2023
Roche cobas KRAS Mutation Test, Roche cobas® DNA S... Roche Molecular Systems, Inc. P140023 S030 05/15/2024
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA... Roche Molecular Systems, Inc. P140023 S001 07/23/2015
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA... Roche Molecular Systems, Inc. P140023 S002 09/24/2015
Roche cobas KRAS Mutation Test, Roche cobas DNA Sa... Roche Molecular Systems, Inc. P140023 S014 07/03/2018
Roche cobas KRAS Mutation Test /Roche cobas DNA Sa... Roche Molecular Systems, Inc. P140023 S011 10/16/2017
Roche cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S028 12/21/2023
Roche cobas DNA Sample Preparation Kit Roche Molecular Systems, Inc. P140023 S029 04/11/2024
cobas® KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S027 12/14/2023
cobas® KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S024 11/29/2022
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