Giardia/ Cryptosporidium Quik Chek

FDA 510(k) K103673 · Techlab Inc., Corporate Research Center

Substantially Equivalent

510(k) numberK103673

Submission

Device name
Giardia/ Cryptosporidium Quik Chek
Applicant
Techlab Inc., Corporate Research Center
Blacksburg, VA, US
Received
December 16, 2010
Decision date
August 18, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MHI – Giardia Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3220
Specialty
Microbiology

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K120001Unigold GiardiaMHI · Traditional Trinity Biotech03/01/2013SE
K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-LfMHI · Traditional Ivd Research, Inc.01/14/2009SE
K031942Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional Remel, Inc.11/18/2003SE
K031834Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional Remel, Inc.11/10/2003SE
K033274Giardia IIMHI · Special Techlab, Inc.11/04/2003SE
K024113IVD Crypto/Giardia DfaMHI · Traditional Ivd Research, Inc.03/05/2003SE
K020583IVD Giardia Antigen Detection Assay Model GL-96MHI · Traditional Ivd Research, Inc.09/17/2002SE
K983399Giardia/Cryptosporidium Combo Rapid AssayMHI · Traditional Genzyme Diagnostics01/11/1999SE
K982711Premier GiardiaMHI · Traditional Meridian Diagnostics, Inc.11/25/1998SE
K982245Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage…MHI · Traditional Biosite Incorporated10/06/1998SE

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K121364Shiga Toxin Quik ChekGMZ · Traditional 10/02/2012SE
K071712Leuko Ez VueDEG · Traditional 12/04/2007SE
K071711Asca-ChekNBT · Traditional 11/07/2007SE

Questions and answers

When was Giardia/ Cryptosporidium Quik Chek cleared by the FDA?

Giardia/ Cryptosporidium Quik Chek (K103673) received a 510(k) decision of Substantially Equivalent on August 18, 2011, 245 days after the submission was received.

What is the product code of K103673?

The FDA product code is MHI – Giardia Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.