510(k) K974694 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
IS-DSDNA TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Dec 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974694
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.