BIOSTAR OIA SHIGATOX— 510(k) K061889

Substantially Equivalent

Inverness Medical-Biostar, Inc.

FDA 510(k) clearance K061889 for BIOSTAR OIA SHIGATOX, Substantially Equivalent on 2006-12-12. Applicant: Inverness Medical-Biostar, Inc..

Clearance details

Applicant: Inverness Medical-Biostar, Inc.
Product code: Code GMZ
Advisory panel: Microbiology
Date received: 2006-07-03
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

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