510(k) K913342 ยท LKJ Antinuclear Antibody, Antigen, Control
AUTOSTAT(TM) ANTI-DSNA
| Applicant | Cogent Diagnotics , Ltd., Dunblane, Fk15 9ep, GB |
| Decision | Substantially Equivalent, May 1, 1992 |
| Received | Jul 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913342
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.