FDA 510(k)

Athelas Home

K-Number: K200828 · 2022-03-22

Decision Date2022-03-22

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Athelas Home is the device name listed in this FDA 510(k) record. The listed applicant is Athelas, Inc.. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K200828. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athelas Home?

Athelas Home is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Athelas, Inc.. The 510(k) number is K200828.

When did Athelas Home receive FDA 510(k) clearance?

Athelas Home received FDA 510(k) clearance on 2022-03-22, under 510(k) number K200828.

Who is the listed applicant for Athelas Home?

The FDA 510(k) record lists Athelas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Athelas Home?

The FDA product code for Athelas Home is GKZ.

Other records listing Athelas, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243348Athelas Home K181288Athelas One

Related Devices (Code: GKZ)

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.