510(k) K901637 ยท LQN Latex Agglutination Assay, Rubella
RESUBMITTED MODIFIED RUBALEX
| Applicant | Orion Corp., 20101 Turku, FI |
| Decision | Substantially Equivalent, Apr 26, 1990 |
| Received | Apr 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901637
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.