Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Nov 22, 2006
| K-number | K062077 |
| Device name | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | DKZ |
| Device class | Class II |
| Decision date | Nov 22, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
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