MODIFICATION TO BIOSTAR OIA SHIGATOX— 510(k) K071799

Name: FDA 510(k) clearance K071799
Creator: U.S. Food and Drug Administration
Published: 2007-10-02

Substantially Equivalent

Iverness Medical Professional Diagnostics

FDA 510(k) clearance K071799 for MODIFICATION TO BIOSTAR OIA SHIGATOX, Substantially Equivalent on 2007-10-02. Applicant: Iverness Medical Professional Diagnostics. Device class: 1.

Clearance details

Applicant: Iverness Medical Professional Diagnostics
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 2007-07-02
Decision date: 2007-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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