Pylori Igg
FDA 510(k) K033067 · Trinity Biotech USA
510(k) numberK033067
Submission
- Device name
- Pylori Igg
- Applicant
- Trinity Biotech USA
Jamestown, NY, US - Received
- September 29, 2003
- Decision date
- November 26, 2003
- 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 |
|---|---|---|
| K140455 | Captia Measles IgmPCL · Traditional | 05/22/2014SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | 07/13/2004SE |
| K033105 | Captia HSV 1 Igg Type Specific Elisa KitMXJ · Traditional | 07/13/2004SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | 11/26/2003SE |
| K033070 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033064 | Mycoplasma IggLON · Traditional | 11/26/2003SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | 11/26/2003SE |
| K993839 | Ena Profile Elisa Test SystemLLL · Traditional | 01/12/2000SE |
| K992665 | Macra Lp(A) Enzyme Immunoassay KitDFC · Traditional | 11/26/1999SE |
Questions and answers
When was Pylori Igg cleared by the FDA?
Pylori Igg (K033067) received a 510(k) decision of Substantially Equivalent on November 26, 2003, 58 days after the submission was received.
What is the product code of K033067?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.