# K940596: Axsym Phenobarbital

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 21, 1994 after 131 days
- Product code: LGQ (Fluorescence Polarization Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081231: Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33 (2008), 1 descendant of its own
- K210858: VITROS Chemistry Products PHBR Slides (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K940596
Methodology: https://510kreport.com/methodology