510(k) K963275 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Sep 13, 1996 |
| Received | Aug 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963275
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.