Ortho-Clinical Diagnostics · Class II · Cleared Aug 7, 2003
| K-number | K031924 |
| Device name | VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 |
| Applicant | Ortho-Clinical Diagnostics |
| Product code | JIT |
| Device class | Class II |
| Decision date | Aug 7, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.1150 |
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