Immunocard Toxins a & B, Model 712050
FDA 510(k) K041003 · Meridian Bioscience, Inc.
510(k) numberK041003
Submission
- Device name
- Immunocard Toxins a & B, Model 712050
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- April 19, 2004
- Decision date
- August 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLH – Reagents, Clostridium Difficile Toxin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin TestLLH · Traditional | First Light Diagnostics, Inc. | 07/08/2021SE |
| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | Genzyme Corporation | 12/21/2010SE |
| K091109 | Xpert C. DifficileLLH · Traditional | Cepheid | 07/09/2009SE |
| K090239 | Progastro CD AssayLLH · Traditional | Prodesse, Inc. | 04/16/2009SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | Techlab, Inc. | 03/26/2009SE |
| K081920 | BD Geneohm Cdiff AssayLLH · Traditional | Bd Diagnostics (Geneohm Sciences, Inc.) | 12/19/2008SE |
| K080931 | Vidas C. Dificile Toxin a & B (Cdab) AssayLLH · Traditional | bioMerieux, Inc. | 06/11/2008SE |
| K072138 | Vidas C. Difficile Toxin A&B (Cdab) Assay, Model: 30 118LLH · Traditional | bioMerieux, Inc. | 12/21/2007SE |
| K050891 | Tox A/B Quick ChekLLH · Traditional | Techlab, Inc. | 07/25/2005SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | Remel, Inc. | 11/15/2004SE |
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| 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 Toxins a & B, Model 712050 cleared by the FDA?
Immunocard Toxins a & B, Model 712050 (K041003) received a 510(k) decision of Substantially Equivalent on August 20, 2004, 123 days after the submission was received.
What is the product code of K041003?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.