Hp-One
FDA 510(k) K012411 · Gi Supply
510(k) numberK012411
Submission
- Device name
- Hp-One
- Applicant
- Gi Supply
Camp Hill, PA, US - Received
- July 30, 2001
- Decision date
- September 25, 2001
- 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 |
| K181379 | H. Pylori Quik 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 |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221042 | Renova RP Centesis PumpBTA · Traditional | 04/19/2023SE |
| K202376 | EverLift Submucosal Lifting AgentPLL · Special | 09/30/2020SE |
| K191923 | EverLift Submucosal Lifting AgentPLL · Traditional | 06/20/2020SE |
| K031360 | Gi Supply Biliary StentFGE · Traditional | 09/24/2003SE |
| K970187 | Runyon Large Volume Paracentesis KitLRO · Traditional | 02/14/1997SE |
| K970186 | Gi Supply Paracentesis PumpBTA · Traditional | 02/14/1997SE |
| K944903 | Hp-FastLYR · Traditional | 04/20/1995SE |
| K931044 | Oxy-BlocMNK · Traditional | 10/04/1993SE |
| K915816 | Bite Block/Mouthpiece for EndoscopyEOQ · Traditional | 03/27/1992SE |
Questions and answers
When was Hp-One cleared by the FDA?
Hp-One (K012411) received a 510(k) decision of Substantially Equivalent on September 25, 2001, 57 days after the submission was received.
What is the product code of K012411?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.