510(k) K041322 ยท DHX System, Test, Carcinoembryonic Antigen
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 17, 2004 |
| Received | May 18, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041322
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.