510(k) K955603 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 19, 1996 |
| Received | Dec 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955603
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.