510(k) K191240 ยท LSR Reagent, Borrelia Serological Reagent
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jul 29, 2019 |
| Received | May 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191240
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.