Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Feb 27, 2009
| K-number | K083680 |
| Device name | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | CEM |
| Device class | Class II |
| Decision date | Feb 27, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.1600 |
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