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KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

DEN150030 Class II Direct
Decision Date
2016-04-25
Sponsor / Applicant
Kronus, Inc.

Technical Specification

510(k) Submission ID DEN150030
Product Code PNI
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5665
Decision Date 2016-04-25
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay received FDA 510(k) clearance under submission number DEN150030, sponsored by Kronus, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-04-25.

Classification & Regulation

This clearance is catalogued under FDA product code PNI and 21 CFR 866.5665, within the Immunology review panel as a Class II device.