510(k) K252627 ยท LSR Reagent, Borrelia Serological Reagent
Lyme-ID IgG Test; Bio-ID800
| Applicant | Inanovate, Inc., Sioux Falls SD, US |
| Decision | Substantially Equivalent, Nov 14, 2025 |
| Received | Aug 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252627
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.