K181288 is an FDA 510(k) clearance for the Athelas One. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Athelas, Inc. (Cupertino, US). The FDA issued a Cleared decision on November 5, 2018, 173 days after receiving the submission on May 16, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K181288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2018 |
| Decision Date | November 05, 2018 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ - Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |