Device Classification Name |
Counter, Differential Cell
|
510(k) Number |
K181288 |
Device Name |
Athelas One |
Applicant |
Athelas Inc. |
10209 Danube Dr. |
Cupertino,
CA
95014
|
|
Applicant Contact |
Tanay Tandon |
Correspondent |
Athelas Inc. |
10209 Danube Dr. |
Cupertino,
CA
95014
|
|
Correspondent Contact |
Tanay Tandon |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 05/16/2018 |
Decision Date | 11/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|