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
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Prognostic Test For Assessment Of Liver Related Disease Progression Devices (Product Code QQB)
1 devices
About Product Code QQB - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QQB since 2021, with 0 receiving FDA clearance (average review time: 603 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.