510(k) K952567 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
AUTOSTATTMII ANTI-DSDNA
| Applicant | Cogent Diagnotics , Ltd., Edinburgh, GB |
| Decision | Substantially Equivalent, Mar 4, 1997 |
| Received | Jun 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952567
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.