K251995 is an FDA 510(k) clearance for the Access anti-HAV IgM. This device is classified as a Hepatitis A Test (antibody And Igm Antibody) (Class II - Special Controls, product code LOL).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 27, 2026, 214 days after receiving the submission on June 27, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3310.
| 510(k) Number | K251995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | January 27, 2026 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LOL — Hepatitis A Test (antibody And Igm Antibody) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3310 |