Wellcolex E.Coli O157:H7
FDA 510(k) K971663 · Murex Biotech , Ltd.
510(k) numberK971663
Submission
- Device name
- Wellcolex E.Coli O157:H7
- Applicant
- Murex Biotech , Ltd.
Dartford,Kent, GB - Received
- May 6, 1997
- Decision date
- December 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222829 | Curian® Shiga ToxinGMZ · Traditional | Meridian Bioscience, Inc. | 04/17/2023SE |
| K121411 | Shiga Toxin ChekGMZ · Traditional | Techlab Inc., Corporate Research Center | 10/02/2012SE |
| K121364 | Shiga Toxin Quik ChekGMZ · Traditional | Techlab Inc., Corporate Research Center | 10/02/2012SE |
| K062546 | Immunocard Stat! Ehec, Model 751630GMZ · Traditional | Meridian Bioscience, Inc. | 02/14/2007SE |
| K061889 | Biostar Oia ShigatoxGMZ · Traditional | Inverness Medical-Biostar, Inc. | 12/12/2006SE |
| K023599 | Immunocard Stat! E. Coli O157 PlusGMZ · Traditional | Meridian Bioscience, Inc. | 01/03/2003SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | Meridian Diagnostics, Inc. | 08/09/1999SE |
| K980507 | Prospect Shiga Toxin Microplate AssayGMZ · Traditional | Alexon - Trend, Inc. | 04/23/1998SE |
| K973457 | Chromalex E. Coli 0157 Latex Test System, Prod. No. 800GMZ · Traditional | Shared Systems, Inc. | 01/02/1998SE |
| K972156 | Quix Rapid E. Coli O157 Strip TestGMZ · Traditional | Guardian Scientific, Corp. | 10/16/1997SE |
Questions and answers
When was Wellcolex E.Coli O157:H7 cleared by the FDA?
Wellcolex E.Coli O157:H7 (K971663) received a 510(k) decision of Substantially Equivalent on December 30, 1997, 238 days after the submission was received.
What is the product code of K971663?
The FDA product code is GMZ – Antigens, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.