The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Glu Slides.
| Device ID | K163433 |
| 510k Number | K163433 |
| Device Name: | VITROS Chemistry Products GLU Slides |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Darlene J. Phillips |
| Correspondent | Darlene J. Phillips Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-09-18 |
| Summary: | summary |