510(k) K970761 ยท LSR Reagent, Borrelia Serological Reagent
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
| Applicant | Cambridge Diagnostics Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Apr 9, 1998 |
| Received | Mar 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970761
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.