ADVIA Centaur Enhanced Liver Fibrosis (ELF)

Prognostic Test For Assessment Of Liver Related Disease Progression

Siemens Healthcare Diagnostics Inc.

The following data is part of a De Novo classification by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Enhanced Liver Fibrosis (elf).

Pre-market Notification Details

DeNovo IDDEN190056
Device Name:ADVIA Centaur Enhanced Liver Fibrosis (ELF)
ClassificationPrognostic Test For Assessment Of Liver Related Disease Progression
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown,  NY  10591
ContactMatthew Gee
Product CodeQQB  
CFR Regulation Number862.1622 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
TypeDirect
Date Received2019-12-26
Decision Date2021-08-20
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414618128 DEN190056 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.