Inova Diagnostics, Inc. · Class II · Cleared Mar 5, 2015
| K-number | K141655 |
| Device name | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS |
| Applicant | Inova Diagnostics, Inc. |
| Product code | OBE |
| Device class | Class II |
| Decision date | Mar 5, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
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