510(k) K003057 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
AUTOSTAT II ENA-4 PROFILE ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Oct 13, 2000 |
| Received | Oct 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003057
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.