510(k) K202215— cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

Substantially Equivalent

Roche Molecular Systems, Inc.

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code QMI
Advisory panel: Microbiology
Date received: 2020-08-06
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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