Tox A/B Quick Chek
FDA 510(k) K050891 · Techlab, Inc.
510(k) numberK050891
Submission
- Device name
- Tox A/B Quick Chek
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- April 8, 2005
- Decision date
- July 25, 2005
- 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 |
| 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 |
|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
Questions and answers
When was Tox A/B Quick Chek cleared by the FDA?
Tox A/B Quick Chek (K050891) received a 510(k) decision of Substantially Equivalent on July 25, 2005, 108 days after the submission was received.
What is the product code of K050891?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.