UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM is an AI-enabled medical device from BECKMAN COULTER, INC., listed by FDA (510(k), K120771) with a decision date of 2013-03-22. Review panel: Hematology.
| FDA submission number | K120771 |
|---|---|
| Pathway | 510(k) |
| Company | BECKMAN COULTER, INC. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2013-03-22 |
| Decision | Substantially Equivalent |
| Product code | GKZ |
| Classification | Counter, Differential Cell |
| Device class | 2 |
| Regulation number | 864.5220 |
| Review time (calendar days) | 373 |
| 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.