Immunocard Stat! Ehec, Model 751630
FDA 510(k) K062546 · Meridian Bioscience, Inc.
510(k) numberK062546
Submission
- Device name
- Immunocard Stat! Ehec, Model 751630
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- August 30, 2006
- Decision date
- February 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| 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 |
| K971663 | Wellcolex E.Coli O157:H7GMZ · Traditional | Murex Biotech , Ltd. | 12/30/1997SE |
| K972156 | Quix Rapid E. Coli O157 Strip TestGMZ · Traditional | Guardian Scientific, Corp. | 10/16/1997SE |
More from Guardian Scientific, Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243922 | RevogeneOOI · Traditional | 03/20/2025SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | 07/03/2023SE |
| K222829 | Curian® Shiga ToxinGMZ · Traditional | 04/17/2023SE |
| K222779 | RevogeneOOI · Special | 01/26/2023SE |
| K220480 | RevogeneOOI · Traditional | 07/11/2022SE |
| K210976 | Curian CampyLQP · Traditional | 12/23/2021SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | 03/13/2020SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | 11/05/2018SE |
| K163273 | TRU LegionellaMJH · Special | 02/21/2017SE |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct…OZX · Traditional | 06/13/2016SE |
Questions and answers
When was Immunocard Stat! Ehec, Model 751630 cleared by the FDA?
Immunocard Stat! Ehec, Model 751630 (K062546) received a 510(k) decision of Substantially Equivalent on February 14, 2007, 168 days after the submission was received.
What is the product code of K062546?
The FDA product code is GMZ – Antigens, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.