# K912024: Automated Biochemical Analyzer (WAK0-20R & 30R)

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jul 19, 1991 after 77 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970986: Wako Direct Bilirubin V (1997), 4 descendants of its own
- K970985: Wako Total Bilirubin V (1997), 3 descendants of its own
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (2005), 2 descendants of its own
- K223078: Atellica® CH Diazo Direct Bilirubin (D_DBil) (2023), 0 descendants of its own
- K152343: Direct Bilirubin (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K912024
Methodology: https://510kreport.com/methodology