Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Feb 5, 1999
| K-number | K984166 |
| Device name | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | CGN |
| Device class | Class II |
| Decision date | Feb 5, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 862.1295 |
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