510(k) K990943 ยท DHX System, Test, Carcinoembryonic Antigen
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 1, 1999 |
| Received | Mar 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990943
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.