510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190056Unknown

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

Siemens Healthcare Diagnostics Inc., Tarrytown NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN190056 is the FDA 510(k) clearance record for ADVIA Centaur Enhanced Liver Fibrosis (ELF), a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code QQB (Prognostic Test For Assessment Of Liver Related Disease Progression). FDA's definition for product code QQB reads: "prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for...". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show no recalls naming DEN190056.

Clearance record

Decision date
Received
(603 days to decision)
Product code
QQB Prognostic Test For Assessment Of Liver Related Disease Progression
Regulation
21 CFR 862.1622
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave., Tarrytown NY
Third party review
No

Clearances, product code QQB

Trailing 12 months

FDA records hold no clearances under product code QQB in the trailing twelve months.

FDA records show no clearances under product code QQB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260