510(k) K003754 ยท LSR Reagent, Borrelia Serological Reagent
IMMUNETICS C6 LYME ELISA KIT
| Applicant | Immunetics, Inc., Cambridge, MA, US |
| Decision | Substantially Equivalent, May 10, 2001 |
| Received | Dec 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003754
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.