Athelas One
Counter, Differential Cell
Athelas Inc.
The following data is part of a premarket notification filed by Athelas Inc. with the FDA for Athelas One.
Pre-market Notification Details
| Device ID | K181288 |
| 510k Number | K181288 |
| Device Name: | Athelas One |
| Classification | Counter, Differential Cell |
| Applicant | Athelas Inc. 10209 Danube Dr. Cupertino, CA 95014 |
| Contact | Tanay Tandon |
| Correspondent | Tanay Tandon Athelas Inc. 10209 Danube Dr. Cupertino, CA 95014 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-11-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001013238 | K181288 | 000 |
| 00860001013221 | K181288 | 000 |
Trademark Results [Athelas One]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATHELAS ONE 88691741 not registered Live/Pending |
Athelas 2019-11-13 |
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