LOL — Hepatitis A Test (Antibody And Igm Antibody) Class II
FDA product code LOL covers "Hepatitis A Test (Antibody And Igm Antibody)", a Class II medical device regulated under 21 CFR 866.3310. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LOL
- Device Class
- Class II
- Regulation Number
- 866.3310
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260048 | roche diagnostics | Elecsys Anti-HAV IgM | April 7, 2026 |
| K251995 | beckman coulter | Access anti-HAV IgM | January 27, 2026 |
| K243846 | beckman coulter | Access anti-HAV | September 9, 2025 |
| K222850 | abbott laboratories | HAVAb IgG II | August 10, 2023 |
| K223403 | diasorin | LIAISON Anti-HAV; LIAISON XS | December 9, 2022 |
| K210272 | diasorin | LIAISON Anti-HAV | February 9, 2021 |
| K193532 | diasorin | LIAISON Anti-HAV Assay | March 2, 2020 |
| K190428 | roche diagnostics | Elecsys Anti-HAV II | August 13, 2019 |
| K161964 | siemens healthcare diagnostics | ADVIA Centaur HAV IgM Assay | October 13, 2016 |
| K160650 | diasorin | LIAISON HAV IgM, LIAISON Control HAV IgM | August 25, 2016 |
| K142758 | siemens healthcare diagnostics | ADVIA Centaur HAV total assay | December 5, 2014 |
| K141116 | diasorin | LIAISON XL ANALYZER | July 25, 2014 |
| K113704 | abbott laboratories | ARCHITECT HAVAB-G | June 28, 2012 |
| K103529 | diasorin | LIAISON XL ANALYZER MODEL 10050 | January 21, 2011 |
| K100903 | roche professional diagnostics | ANTI-HAV | October 5, 2010 |
| K093955 | roche diagnostics | ANTI-HAV IGM | June 22, 2010 |
| K092355 | bio-rad laboratories | MONOLISA ANTI-HAV EIA | October 29, 2009 |
| K092353 | bio-rad laboratories | MONOLISA ANTI-HAV IGM EIA | October 29, 2009 |
| K082049 | diasorin | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | December 5, 2008 |
| K082050 | diasorin | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | November 3, 2008 |