510(k) K843978 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
| Applicant | Behring Diagnostics, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Dec 18, 1984 |
| Received | Oct 11, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843978
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.