510(k) K896347 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 5, 1989 |
| Received | Nov 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896347
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.