Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Jan 6, 2005
| K-number | K042479 |
| Device name | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | LCD |
| Device class | Class II |
| Decision date | Jan 6, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 862.3450 |
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