510(k) K990796 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Apr 28, 1999 |
| Received | Mar 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990796
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.