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FDA 510(k) Applications Submitted by Sumedha Sinha
FDA 510(k) Number
Submission Date
Device Name
Applicant
K243400
10/31/2024
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
Roche Molecular Systems, Inc.
K243406
11/01/2024
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Roche Molecular Systems, Inc.
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