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AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

K172461 Class II Traditional
Decision Date
2018-03-23
Sponsor / Applicant
Aesku.Diagnostics GmbH & Co. KG

Technical Specification

510(k) Submission ID K172461
Product Code MOB
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5660
Decision Date 2018-03-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin received FDA 510(k) clearance under submission number K172461, sponsored by Aesku.Diagnostics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2018-03-23.

Classification & Regulation

This clearance is catalogued under FDA product code MOB and 21 CFR 866.5660, within the Immunology review panel as a Class II device.