510(k) K230863 ยท LSR Reagent, Borrelia Serological Reagent
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
| Applicant | Zeus Scientific, Branchburg NJ, US |
| Decision | Substantially Equivalent, Jul 13, 2023 |
| Received | Mar 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230863
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.