DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER is an AI-enabled medical device from CELLAVISION AB, listed by FDA (510(k), K003301) with a decision date of 2001-03-15. Review panel: Hematology.
| FDA submission number | K003301 |
|---|---|
| Pathway | 510(k) |
| Company | CELLAVISION AB |
| Review panel (specialty) | Hematology |
| FDA decision date | 2001-03-15 |
| Decision | Substantially Equivalent |
| Product code | JOY |
| Classification | Device, Automated Cell-Locating |
| Device class | 2 |
| Regulation number | 864.5260 |
| Review time (calendar days) | 146 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.