Devices · Athelas Inc.

Athelas Home

Athelas Inc. is listed for Athelas Home (K200828). The FDA list gives March 22, 2022 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GKZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200828

Official FDA database record

Date of final decision

March 22, 2022

Company on the FDA list

Athelas Inc.

Lead panel

Hematology

Primary product code

GKZ

openFDA device name for the code

Counter, Differential Cell

Device class

2

Regulation number

864.5220

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary