C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96
FDA 510(k) K032897 · Ivd Research, Inc.
510(k) numberK032897
Submission
- Device name
- C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96
- Applicant
- Ivd Research, Inc.
Carlsbad, CA, US - Received
- September 17, 2003
- Decision date
- May 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K081064 | Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-LfMHI · Traditional | 01/14/2009SE |
| K031059 | IVD Cryptosporidium Antigen Detection Assay, Model CP-96MHJ · Traditional | 07/10/2003SE |
| K024113 | IVD Crypto/Giardia DfaMHI · Traditional | 03/05/2003SE |
| K020583 | IVD Giardia Antigen Detection Assay Model GL-96MHI · Traditional | 09/17/2002SE |
Questions and answers
When was C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96 cleared by the FDA?
C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96 (K032897) received a 510(k) decision of Substantially Equivalent on May 27, 2004, 253 days after the submission was received.
What is the product code of K032897?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.