# K941615: Axsym Valproic Acid

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 16, 1994 after 134 days
- Product code: LEG (Enzyme Immunoassay, Valproic Acid)
- Device class: 2
- Regulation: 21 CFR 862.3645
- 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; 3 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090358: Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35 (2009), 0 descendants of its own
- K030405: QMS / Multigent Valproic Acid Reagent, Part #396075 (2003), 0 descendants of its own
- K981403: Immage Immunochemistry System Valproic Acid (Vpa) Reagent (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K941615
Methodology: https://510kreport.com/methodology