Ortho Clinical Diagnostics · Class II · Cleared Oct 4, 2021
| K-number | K201312 |
| Device name | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack |
| Applicant | Ortho Clinical Diagnostics |
| Product code | NBC |
| Device class | Class II |
| Decision date | Oct 4, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 862.1117 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov