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Athelas

Athelas is a 510k Class 1 pre-cleared device that has developed technology under the FDA 510k product classes of IBJ, KPA, GKM, and GHO.

FDA 510k

510k Class 1 products are regulated and classified by the FDA, and are seen as having "non-significant risk" to users. Class 1 compromises of cleared tools and methodologies that may be combined and applied in unison for some novel application. Athelas is a registered establishment with the FDA, and has filed our Class 1 devices with the organization. Below is a summary of Athelas's Class 1 listed technology. The technical specifications of these product codes are provided here: FDA Class 1

Automated Cell Staining Mechanism: KPA

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Under FDA product code KPA Athelas has developed a staining mechanism to interface with blood cells and highlight them for morphological analysis. All development and production of this technology has been conducted in regulation with the assigned FDA regulatory reference number 864.3800.

Hemacytometer Representation and Collection Apparatus: GKM and GHO

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Under FDA product codes GKM and GHO Athelas has developed a counting mechanism to collect and flow cells into Statistically Representative Field of Views for analysis. All development and production of this technology has been conducted in regulation with the assigned FDA regulatory reference number 864.6160.

Imager: IBJ

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Under FDA product codes IBJ Athelas has developed a portable optical unit for sample imaging. All development and production of this technology has been conducted inregulation with the assigned FDA regulatory reference number 864.3600