510(k) K001127 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Aug 30, 2000 |
| Received | Apr 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001127
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.