510(k) K994424 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Feb 18, 2000 |
| Received | Dec 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994424
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.