510(k) K911848 ยท LKP Anti-Sm Antibody, Antigen And Control
IMMUNOWELL RNP/SM ANTIBODY TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 7, 1991 |
| Received | Apr 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911848
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.