Inova Diagnostics, Inc. · Class II · Cleared Jun 1, 2016
| K-number | K152635 |
| Device name | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls |
| Applicant | Inova Diagnostics, Inc. |
| Product code | LLL |
| Device class | Class II |
| Decision date | Jun 1, 2016 |
| 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