510(k) K983513 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 3, 1998 |
| Received | Oct 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983513
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.