Ortho-Clinical Diagnostics, Inc. · Class I · Cleared Aug 30, 2001
| K-number | K012593 |
| Device name | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | LBR |
| Device class | Class I |
| Decision date | Aug 30, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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