510(k) K925783 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
AUTOSTAT ANTI-DSDNA
| Applicant | Cogent Diagnotics , Ltd., Dunblane, Fk15 9ep, GB |
| Decision | Substantially Equivalent, Mar 22, 1993 |
| Received | Nov 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925783
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.