510(k) K882999 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jan 31, 1989 |
| Received | Jul 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882999
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.