FDA 510(k) Applications Submitted by Kaitlyn Hameister

FDA 510(k) Number Submission Date Device Name Applicant
K200065 01/13/2020 cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K210234 01/28/2021 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K191729 06/27/2019 Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System Roche Molecular Systems, Inc.
K212427 08/04/2021 cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K213822 12/08/2021 cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.


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