cobas HSV 1 and 2 Test— 510(k) K150617

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K150617 for cobas HSV 1 and 2 Test, Substantially Equivalent on 2015-06-01. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code OQO
Advisory panel: Microbiology
Date received: 2015-03-10
Decision date: 2015-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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