510(k) K233367 ยท LSR Reagent, Borrelia Serological Reagent
iDart Lyme IgG ImmunoBlot Kit
| Applicant | Id-Fish Technology, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Aug 12, 2024 |
| Received | Oct 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233367
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.