510(k) K001875 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | Jun 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001875
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.