510(k) K820296 ยท DIF Drug Mixture Control Materials
STRATUS TDM CONTROL, LEVELS I,II,III
| Applicant | American Dade, Mchenry IL, US |
| Decision | Substantially Equivalent, May 14, 1982 |
| Received | Feb 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820296
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.