cobas Cdiff Test— 510(k) K142422

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K142422 for cobas Cdiff Test, Substantially Equivalent on 2015-05-20. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code OZN
Advisory panel: Microbiology
Date received: 2014-08-28
Decision date: 2015-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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