510(k) K810077 ยท DIF Drug Mixture Control Materials
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
| Applicant | Hyland Therapeutic Div., Travenol Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 28, 1981 |
| Received | Jan 13, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810077
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.