Cleared Traditional

Athelas One

K181288 · Athelas, Inc. · Hematology
Nov 2018
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K181288 is an FDA 510(k) clearance for the Athelas One, 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 review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K181288 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220