510(k) K990016 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 19, 1999 |
| Received | Jan 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990016
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.