Ortho-Clinical Diagnostics · Class II · Cleared Jun 21, 2000
| K-number | K001769 |
| Device name | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT |
| Applicant | Ortho-Clinical Diagnostics |
| Product code | CGX |
| Device class | Class II |
| Decision date | Jun 21, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 862.1225 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov