Premier HpSA Flex (619096)
FDA 510(k) K230901 · Meridian Bioscience, Inc.
510(k) numberK230901
Submission
- Device name
- Premier HpSA Flex (619096)
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- March 31, 2023
- Decision date
- July 3, 2023
- 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 |
| 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 |
| 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 |
|---|---|---|
| K243922 | RevogeneOOI · Traditional | 03/20/2025SE |
| K222829 | Curian® Shiga ToxinGMZ · Traditional | 04/17/2023SE |
| K222779 | RevogeneOOI · Special | 01/26/2023SE |
| K220480 | RevogeneOOI · Traditional | 07/11/2022SE |
| K210976 | Curian CampyLQP · Traditional | 12/23/2021SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | 03/13/2020SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | 11/05/2018SE |
| K163273 | TRU LegionellaMJH · Special | 02/21/2017SE |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct…OZX · Traditional | 06/13/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | 03/14/2016SE |
Questions and answers
When was Premier HpSA Flex (619096) cleared by the FDA?
Premier HpSA Flex (619096) (K230901) received a 510(k) decision of Substantially Equivalent on July 3, 2023, 94 days after the submission was received.
What is the product code of K230901?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.