QQB · Class II · 21 CFR 862.1622

FDA Product Code QQB: Prognostic Test For Assessment Of Liver Related Disease Progression

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 Diagnosis Of Any Disease, For Monitoring The Effect Of Any Therapeutic Product, For Assessing Progression To Hepatocellular Carcinoma, Or For Assessing Disease Progression In Individuals With Viral Hepatitis. It Is Also Not Intended For The Detection Of Viruses, Viral Antigens, Or Antibodies To Viruses.

Leading manufacturers include Siemens Healthcare Diagnostics, Inc..

1
Total
0
Cleared
603d
Avg days
2021
Since

List of Prognostic Test For Assessment Of Liver Related Disease Progression devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Prognostic Test For Assessment Of Liver Related Disease Progression devices (product code QQB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →