# P160016: VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

- Pathway: PMA
- Applicant: Fujirebio Europe N.V.
- Decided: Mar 14, 2017 after 281 days
- Product code: OBF (Assay, Genotyping, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P160016
Methodology: https://510kreport.com/methodology