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cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit — Roche Molecular Systems, Inc. (510(k) DEN200015)

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit — Roche Molecular Systems, Inc. (510(k) DEN200015) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit; Applicant: Roche Molecular Systems,

Device namecobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
ApplicantRoche Molecular Systems, Inc.
Clearance track510(k)
Submission numberDEN200015
DecisionUnknown
Decision date2020-07-30
Date received2020-03-02
Product codeQLX
Device class2
Medical specialtyMicrobiology
Applicant locationCA, US
SourceopenFDA device

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