510(k) K002215 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian Eh26 0pl, GB |
| Decision | Substantially Equivalent, Sep 28, 2000 |
| Received | Jul 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002215
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.