Shiga Toxin Quik Chek

FDA 510(k) K121364 · Techlab Inc., Corporate Research Center

Substantially Equivalent

510(k) numberK121364

Submission

Device name
Shiga Toxin Quik Chek
Applicant
Techlab Inc., Corporate Research Center
Blacksburg, VA, US
Received
May 7, 2012
Decision date
October 2, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GMZ – Antigens, All Types, Escherichia Coli
Device class
Class I (low risk)
Regulation
21 CFR 866.3255
Specialty
Microbiology

Other 510(k)s with product code GMZ

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K222829Curian® Shiga ToxinGMZ · Traditional Meridian Bioscience, Inc.04/17/2023SE
K121411Shiga Toxin ChekGMZ · Traditional Techlab Inc., Corporate Research Center10/02/2012SE
K062546Immunocard Stat! Ehec, Model 751630GMZ · Traditional Meridian Bioscience, Inc.02/14/2007SE
K061889Biostar Oia ShigatoxGMZ · Traditional Inverness Medical-Biostar, Inc.12/12/2006SE
K023599Immunocard Stat! E. Coli O157 PlusGMZ · Traditional Meridian Bioscience, Inc.01/03/2003SE
K990263Immunocard Stat! E. Coli O157:H7GMZ · Traditional Meridian Diagnostics, Inc.08/09/1999SE
K980507Prospect Shiga Toxin Microplate AssayGMZ · Traditional Alexon - Trend, Inc.04/23/1998SE
K973457Chromalex E. Coli 0157 Latex Test System, Prod. No. 800GMZ · Traditional Shared Systems, Inc.01/02/1998SE
K971663Wellcolex E.Coli O157:H7GMZ · Traditional Murex Biotech , Ltd.12/30/1997SE
K972156Quix Rapid E. Coli O157 Strip TestGMZ · Traditional Guardian Scientific, Corp.10/16/1997SE

More from Guardian Scientific, Corp.

510(k)DeviceDecision
K121411Shiga Toxin ChekGMZ · Traditional 10/02/2012SE
K103673Giardia/ Cryptosporidium Quik ChekMHI · Traditional 08/18/2011SE
K071712Leuko Ez VueDEG · Traditional 12/04/2007SE
K071711Asca-ChekNBT · Traditional 11/07/2007SE

Questions and answers

When was Shiga Toxin Quik Chek cleared by the FDA?

Shiga Toxin Quik Chek (K121364) received a 510(k) decision of Substantially Equivalent on October 2, 2012, 148 days after the submission was received.

What is the product code of K121364?

The FDA product code is GMZ – Antigens, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.