Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack— 510(k) K163085

Substantially Equivalent

Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC

FDA 510(k) clearance K163085 for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack, Substantially Equivalent on 2017-02-14. Applicant: Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC.

Clearance details

Applicant: Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Product code: Code OZN
Advisory panel: Microbiology
Date received: 2016-11-03
Decision date: 2017-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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