Vidas C. Dificile Toxin a & B (Cdab) Assay
FDA 510(k) K080931 · bioMerieux, Inc.
510(k) numberK080931
Submission
- Device name
- Vidas C. Dificile Toxin a & B (Cdab) Assay
- Applicant
- bioMerieux, Inc.
Hazelwood, MO, US - Received
- April 2, 2008
- Decision date
- June 11, 2008
- 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
Other 510(k)s with product code LLH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K041003 | Immunocard Toxins a & B, Model 712050LLH · Traditional | Meridian Bioscience, Inc. | 08/20/2004SE |
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Questions and answers
When was Vidas C. Dificile Toxin a & B (Cdab) Assay cleared by the FDA?
Vidas C. Dificile Toxin a & B (Cdab) Assay (K080931) received a 510(k) decision of Substantially Equivalent on June 11, 2008, 70 days after the submission was received.
What is the product code of K080931?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.