Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Nov 10, 2004
| K-number | K042475 |
| Device name | VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | CFN |
| Device class | Class II |
| Decision date | Nov 10, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.5510 |
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