Ortho-Clinical Diagnostics · Class II · Cleared Oct 22, 2010
| K-number | K101921 |
| Device name | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT |
| Applicant | Ortho-Clinical Diagnostics |
| Product code | CEW |
| Device class | Class II |
| Decision date | Oct 22, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 862.1545 |
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