meddevicedb.com FDA Device Reference

Lumipulse G ß-Amyloid Ratio (1-42/1-40)

DEN200072 Class II Direct
Decision Date
2022-05-04
Sponsor / Applicant
Fujirebio Diagnostics,Inc.

Technical Specification

510(k) Submission ID DEN200072
Product Code QSE
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5840
Decision Date 2022-05-04
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

Lumipulse G ß-Amyloid Ratio (1-42/1-40) received FDA 510(k) clearance under submission number DEN200072, sponsored by Fujirebio Diagnostics,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 2022-05-04.

Classification & Regulation

This clearance is catalogued under FDA product code QSE and 21 CFR 866.5840, within the Immunology review panel as a Class II device.