The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Cl-slides, Vitros Chemistry Products Eco2 Slides, Vitros Chemistry Products Glu Slides.
| Device ID | K182072 |
| 510k Number | K182072 |
| Device Name: | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | CGZ |
| Subsequent Product Code | CGA |
| Subsequent Product Code | KHS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-10-30 |
| Summary: | summary |