510(k) K253687 ยท SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
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| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253687
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.