510(k) K911393 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBENOSTIKA IGG MICROELISA SYSTEM
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Apr 29, 1991 |
| Received | Mar 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911393
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.