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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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