510(k) K182072 ยท CGZ Electrode, Ion-Specific, Chloride
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2023 | Ortho-Clinical Diagnostics, INc. VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only.
VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using Open, Classified |
KHS | None listed |
| Jun 17, 2019 | Ortho-Clinical Diagnostics VITROS Chemistry Products GLU Slides-Product Code:1707801.
IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.