FDA 510(k)

Athelas One

K-Number: K181288 · 2018-11-05

Decision Date2018-11-05

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Athelas One is the device name listed in this FDA 510(k) record. The listed applicant is Athelas, Inc.. It received FDA 510(k) clearance on 2018-11-05 under 510(k) number K181288. 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 One?

Athelas One is a medical device that received FDA 510(k) clearance on 2018-11-05. The listed applicant is Athelas, Inc.. The 510(k) number is K181288.

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

Athelas One received FDA 510(k) clearance on 2018-11-05, under 510(k) number K181288.

Who is the listed applicant for Athelas One?

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 One?

The FDA product code for Athelas One 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 K200828Athelas Home

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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.