Vidas Clostridium Difficile Toxin a (Cda) Assay
FDA 510(k) K905211 · Vitek Systems, Inc.
510(k) numberK905211
Submission
- Device name
- Vidas Clostridium Difficile Toxin a (Cda) Assay
- Applicant
- Vitek Systems, Inc.
Rockland, MA, US - Received
- November 20, 1990
- Decision date
- October 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Remel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | 06/24/1991SE |
Questions and answers
When was Vidas Clostridium Difficile Toxin a (Cda) Assay cleared by the FDA?
Vidas Clostridium Difficile Toxin a (Cda) Assay (K905211) received a 510(k) decision of Substantially Equivalent on October 11, 1991, 325 days after the submission was received.
What is the product code of K905211?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.