Quix Rapid E. Coli O157 Strip Test

FDA 510(k) K972156 · Guardian Scientific, Corp.

Substantially Equivalent

510(k) numberK972156

Submission

Device name
Quix Rapid E. Coli O157 Strip Test
Applicant
Guardian Scientific, Corp.
Columbia, MD, US
Received
June 9, 1997
Decision date
October 16, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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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

More from Murex Biotech , Ltd.

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K954994TrustGMQ · Traditional 10/18/1996SE
K954995Quix Rapid Cholera Strip TestGSQ · Traditional 08/15/1996SE
K954993Quix Rapid Pregnancy Strip TestJHI · Traditional 12/13/1995SE

Questions and answers

When was Quix Rapid E. Coli O157 Strip Test cleared by the FDA?

Quix Rapid E. Coli O157 Strip Test (K972156) received a 510(k) decision of Substantially Equivalent on October 16, 1997, 129 days after the submission was received.

What is the product code of K972156?

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