Gap-Igg
FDA 510(k) K900343 · Biomerica, Inc.
510(k) numberK900343
Submission
- Device name
- Gap-Igg
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- January 23, 1990
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | 12/15/2023SE |
| K003856 | Ez-Hcg Urine(Pregnancy Test)JHI · Traditional | 02/21/2001SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | 09/24/1998SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | 09/19/1996SE |
| K960412 | T-3 Microwell Eia Model 7013CDP · Traditional | 03/19/1996SE |
| K954256 | Anti-TpoJNL · Traditional | 11/27/1995SE |
| K950588 | T4 Microwell Eia (Enzyme IMMUNOASSAY0KLI · Traditional | 06/29/1995SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | 07/18/1994SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | 03/04/1992SE |
Questions and answers
When was Gap-Igg cleared by the FDA?
Gap-Igg (K900343) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 576 days after the submission was received.
What is the product code of K900343?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.