510(k) K994004 ยท LSR Reagent, Borrelia Serological Reagent
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Nov 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994004
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.