Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Device Classification Name prognostic test for assessment of liver related disease progression
De Novo Number DEN190056
Device Name ADVIA Centaur Enhanced Liver Fibrosis (ELF)
Requester
siemens healthcare diagnostics inc.
511 benedict ave
tarrytown,  NY  10591
Contact matthew gee
Regulation Number862.1622
Classification Product Code
QQB  
Date Received12/26/2019
Decision Date 08/20/2021
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-