FDA 510(k) Applications Submitted by Deborah Leu

FDA 510(k) Number Submission Date Device Name Applicant
K240197 01/25/2024 cobas« liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc.
K240217 01/26/2024 cobas« liat CT/NG nucleic acid test Roche Molecular Systems, Inc.
K243346 10/28/2024 cobas liat SARS-CoV-2 v2 nucleic acid test Roche Molecular Systems, Inc.


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