510(k) K912292 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
DIASTAT ANTI-JO-1 KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | May 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912292
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.