510(k) K962919 ยท KHO Fluorometer, For Clinical Use
VITROS IMMUNODIAGNOSTIC SYSTEM
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 18, 1996 |
| Received | Jul 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System
Product Code: 1922814
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, usi Terminated |
KHO | None listed |
| Feb 20, 2019 | Ortho-Clinical Diagnostics VITROS ECi Immunodiagnostic System Refurbished
Product Code: 6801059
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interes Terminated |
KHO | None listed |
| Jan 27, 2012 | Ortho-Clinical Diagnostics VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have So Terminated |
KHO | None listed |
| Jan 27, 2012 | Ortho-Clinical Diagnostics VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that hav Terminated |
KHO | None listed |
| Nov 15, 2005 | Ortho-Clinical Diagnostics Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Rea Terminated |
KHO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.