Ortho-Clinical Diagnostics · Class II · Cleared Jan 5, 2007
| K-number | K062165 |
| Device name | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
| Applicant | Ortho-Clinical Diagnostics |
| Product code | DIS |
| Device class | Class II |
| Decision date | Jan 5, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 862.3150 |
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