Cleared Traditional

SHIGA TOXIN CHEK

K121411 · Techlab Inc., Corporate Research Center · Microbiology
Oct 2012
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K121411 is an FDA 510(k) clearance for the SHIGA TOXIN 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, 144 days after receiving the submission on May 11, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K121411 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2012
Decision Date October 02, 2012
Days to Decision 144 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

Similar Devices — GMZ Antigens, All Types, Escherichia Coli

All 13
Curian? Shiga Toxin
K222829 · Meridian Bioscience, Inc. · Apr 2023
SHIGA TOXIN QUIK CHEK
K121364 · Techlab Inc., Corporate Research Center · Oct 2012
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546 · Meridian Bioscience, Inc. · Feb 2007
BIOSTAR OIA SHIGATOX
K061889 · Inverness Medical-Biostar, Inc. · Dec 2006
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · Meridian Bioscience, Inc. · Jan 2003
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · Meridian Diagnostics, Inc. · Aug 1999