510(k) DEN190056
- Device
- ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 510(k) number
- DEN190056
- Product code
- QQB
- Decision
- Unknown (DENG)
- Decision date
- 2021-08-20
- Date received
- 2019-12-26
- Regulation
- 862.1622
- Classification name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Matthew Gee
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 1219913
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA