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ADVIA Centaur Enhanced Liver Fibrosis (ELF)

DEN190056 Class II Direct
Decision Date
2021-08-20
Sponsor / Applicant
Siemens Healthcare Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN190056
Product Code QQB
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1622
Decision Date 2021-08-20
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

ADVIA Centaur Enhanced Liver Fibrosis (ELF) received FDA 510(k) clearance under submission number DEN190056, sponsored by Siemens Healthcare Diagnostics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2021-08-20.

Classification & Regulation

This clearance is catalogued under FDA product code QQB and 21 CFR 862.1622, within the Clinical Chemistry review panel as a Class II device.