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

Name: FDA 510(k) clearance K113433
Creator: U.S. Food and Drug Administration
Published: 2012-04-04

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.. Device class: 1.

Clearance details

Applicant: Focus Diagnostics, Inc.
Product code: Code OMN
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2011-11-21
Decision date: 2012-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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