cobas BKV— 510(k) K203220

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K203220 for cobas BKV, Substantially Equivalent on 2021-01-29. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code QLX
Advisory panel: Microbiology
Date received: 2020-11-02
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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