SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT— 510(k) K113433

Substantially Equivalent

Focus Diagnostics, Inc.

FDA 510(k) clearance K113433 for SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT, Substantially Equivalent on 2012-04-04. Applicant: Focus Diagnostics, Inc..

Clearance details

Applicant: Focus Diagnostics, Inc.
Product code: Code OMN
Advisory panel: Microbiology
Date received: 2011-11-21
Decision date: 2012-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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