BD Geneohm Cdiff Assay
FDA 510(k) K081920 · Bd Diagnostics (Geneohm Sciences, Inc.)
510(k) numberK081920
Submission
- Device name
- BD Geneohm Cdiff Assay
- Applicant
- Bd Diagnostics (Geneohm Sciences, Inc.)
San Diego, CA, US - Received
- July 3, 2008
- Decision date
- December 19, 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 |
| 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 |
| K041003 | Immunocard Toxins a & B, Model 712050LLH · Traditional | Meridian Bioscience, Inc. | 08/20/2004SE |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093346 | BD Geneohm Mrsa Acp AssayNQX · Traditional | 12/15/2009SE |
Questions and answers
When was BD Geneohm Cdiff Assay cleared by the FDA?
BD Geneohm Cdiff Assay (K081920) received a 510(k) decision of Substantially Equivalent on December 19, 2008, 169 days after the submission was received.
What is the product code of K081920?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.