# P890019: AB -Havk

- Pathway: PMA
- Applicant: Diasorin
- Decided: Jul 13, 1990 after 485 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K063318: Monolisa Anti-Hav Eia (2007), 1 descendant of its own
- K092355: Monolisa Anti-Hav Eia (2009), 0 descendants of its own
- K082049: Liaison Anti-Hav Assay, Liaison Control Anti-Hav (2008), 0 descendants of its own

Source page: https://510kreport.com/device/P890019
Methodology: https://510kreport.com/methodology