510(k) K983690 ยท MOI System, Test, Immunological, Antigen, Tumor
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 2, 1999 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983690
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.