Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Jun 17, 2004
| K-number | K041322 |
| Device name | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | DHX |
| Device class | Class II |
| Decision date | Jun 17, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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