510(k) K210385— cobas Cdiff nucleic acid test for use on the cobas Liat System

Substantially Equivalent

Roche Molecular Systems, Inc.

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code OZN
Advisory panel: Microbiology
Date received: 2021-02-09
Decision date: 2021-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

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