H. Pylori Quik Chek
FDA 510(k) K181379 · Techlab, Inc.
510(k) numberK181379
Submission
- Device name
- H. Pylori Quik Chek
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- May 24, 2018
- Decision date
- August 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
Other 510(k)s with product code LYR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | Biomerica, Inc. | 12/15/2023SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | Meridian Bioscience, Inc. | 07/03/2023SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | Meridian Bioscience, Inc. | 03/13/2020SE |
| K183573 | Vstrip H. pylori Antigen Rapid TestLYR · Traditional | Panion & BF Biotech, Inc. | 03/14/2019SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | Meridian Bioscience, Inc. | 11/05/2018SE |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR · Traditional | DiaSorin, Inc. | 08/31/2018SE |
| K181400 | H. Pylori ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR · Traditional | DiaSorin, Inc. | 07/22/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | Meridian Bioscience, Inc. | 03/14/2016SE |
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…LYR · Special | Alere San Diego, Incorporated | 08/12/2015SE |
More from Alere San Diego, Incorporated
| 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 |
| 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 |
| K051927 | Techlab Asca-ChekNBT · Traditional | 04/06/2006SE |
Questions and answers
When was H. Pylori Quik Chek cleared by the FDA?
H. Pylori Quik Chek (K181379) received a 510(k) decision of Substantially Equivalent on August 21, 2018, 89 days after the submission was received.
What is the product code of K181379?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.