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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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