510(k) K242872 ยท LSR Reagent, Borrelia Serological Reagent
iDart Lyme IgM ImmunoBlot Kit
| Applicant | Id-Fish Technology, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Jun 12, 2025 |
| Received | Sep 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242872
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.