Ortho-Clinical Diagnostics · Class II · Cleared Oct 19, 2004
| K-number | K042494 |
| Device name | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III |
| Applicant | Ortho-Clinical Diagnostics |
| Product code | CZW |
| Device class | Class II |
| Decision date | Oct 19, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.5240 |
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