Cleared Traditional

BIOSTAR OIA SHIGATOX

K061889 · Inverness Medical-Biostar, Inc. · Microbiology

Dec 2006

Decision

162d

Days

Class 1

Risk

About This 510(k) Submission

K061889 is an FDA 510(k) clearance for the BIOSTAR OIA SHIGATOX, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Inverness Medical-Biostar, Inc. (Louisville, US). The FDA issued a Cleared decision on December 12, 2006, 162 days after receiving the submission on July 3, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number	K061889 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2006
Decision Date	December 12, 2006
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF