510(k) K943630 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
DIASTAT ANTI-MPO (PANCA) KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Mar 6, 1995 |
| Received | Jul 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943630
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.