510(k) K982649 ยท DIF Drug Mixture Control Materials
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 12, 1998 |
| Received | Jul 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982649
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.