510(k) K983875 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 14, 1999 |
| Received | Nov 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Ortho-Clinical Diagnostics VITROS CA 125 II Calibrators
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative mea Terminated |
LTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.