FDA 510(k) Applications Submitted by Rita Hoady

FDA 510(k) Number Submission Date Device Name Applicant
DEN200015 03/02/2020 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
K202215 08/06/2020 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
K213804 12/06/2021 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems Roche Molecular Systems, Inc.


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