510(k) K860097 ยท DIF Drug Mixture Control Materials
THERAPEUTIC DRUG (TDM) CALIBRATOR
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Feb 11, 1986 |
| Received | Jan 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860097
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.