ADVIA Centaur Enhanced Liver Fibrosis (ELF)— 510(k) DEN190056

Name: FDA 510(k) clearance DEN190056
Creator: U.S. Food and Drug Administration
Published: 2021-08-20

Unknown

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance DEN190056 for ADVIA Centaur Enhanced Liver Fibrosis (ELF), Unknown on 2021-08-20. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code QQB
Device class: Class 2
Regulation: 21 CFR 862.1622
Advisory panel: Clinical Chemistry
Date received: 2019-12-26
Decision date: 2021-08-20
Decision: Unknown
Clearance type: Direct
Location: Tarrytown, NY, US

View on FDA.gov ↗

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