Cleared Traditional

SHIGA TOXIN QUIK CHEK

K121364 · Techlab Inc., Corporate Research Center · Microbiology
Oct 2012
Decision
148d
Days
Class 1
Risk

About This 510(k) Submission

K121364 is an FDA 510(k) clearance for the SHIGA TOXIN QUIK CHEK, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on October 2, 2012, 148 days after receiving the submission on May 7, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K121364 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2012
Decision Date October 02, 2012
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GMZ — Antigens, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255

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