Vidas C. Difficile Toxin a II Assay
FDA 510(k) K964887 · Biomerieux Vitek, Inc.
510(k) numberK964887
Submission
- Device name
- Vidas C. Difficile Toxin a II Assay
- Applicant
- Biomerieux Vitek, Inc.
Rockland, MA, US - Received
- December 6, 1996
- Decision date
- April 8, 1997
- 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 |
| 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 |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
| K942050 | Hemolab Cofac IxGJT · Traditional | 05/19/1995SE |
Questions and answers
When was Vidas C. Difficile Toxin a II Assay cleared by the FDA?
Vidas C. Difficile Toxin a II Assay (K964887) received a 510(k) decision of Substantially Equivalent on April 8, 1997, 123 days after the submission was received.
What is the product code of K964887?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.