510(k) K983921 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
AUTOSTAT II ENA SCREEN ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Dec 28, 1998 |
| Received | Nov 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983921
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.