LOL
- Product code
- LOL
- Device name
- Hepatitis A Test (Antibody And Igm Antibody)
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3310
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 26 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260048 | 2026-04-07 | Roche Diagnostics | Elecsys Anti-HAV IgM | |
| K251995 | 2026-01-27 | Beckman Coulter, Inc. | Access anti-HAV IgM | |
| K243846 | 2025-09-09 | Beckman Coulter, Inc. | Access anti-HAV |
Official FDA classification page: LOL
Classification and pathway per current FDA publications. Data from openFDA (CC0).