Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Feb 2, 1999
| K-number | K983690 |
| Device name | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | MOI |
| Device class | Class II |
| Decision date | Feb 2, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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