510(k) K243776 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
| Applicant | Zeus Scientific, Branchburg NJ, US |
| Decision | Substantially Equivalent, May 7, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243776
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.