Prospect Clostridium Difficile Toxin A/B Microplate Assay
FDA 510(k) K033479 · Remel, Inc.
510(k) numberK033479
Submission
- Device name
- Prospect Clostridium Difficile Toxin A/B Microplate Assay
- Applicant
- Remel, Inc.
Ramsey, MN, US - Received
- November 3, 2003
- Decision date
- February 26, 2004
- 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 |
|---|---|---|
| K162620 | Remel Spectra ESBLJSO · Traditional | 05/01/2017SE |
| K131804 | Remel Xpect Flu A&BGNX · Special | 07/12/2013SE |
| K092407 | Remel Spectra MrsaJSO · Traditional | 10/08/2010SE |
| K072827 | Rpmi 1640 Agar W/Mops and 2% GlucoseMJE · Traditional | 11/26/2007SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | 11/15/2004SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | 11/14/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | 11/10/2003SE |
| K031565 | Xpect Influenza A/BPSZ · Traditional | 07/17/2003SE |
| K013711 | Bacti-Swab DryLIO · Traditional | 11/26/2001SE |
Questions and answers
When was Prospect Clostridium Difficile Toxin A/B Microplate Assay cleared by the FDA?
Prospect Clostridium Difficile Toxin A/B Microplate Assay (K033479) received a 510(k) decision of Substantially Equivalent on February 26, 2004, 115 days after the submission was received.
What is the product code of K033479?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.