# K854811: Ics Pab Prealbumin Reagent Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jan 24, 1986 after 52 days
- Product code: DDS (Prealbumin, Fitc, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5060
- 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; 2 cite 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
- K994168: Synchron LX Systems Prealbumin Calibrator (2000), 1 descendant of its own
- K994169: Synchron CX Systems Prealbumin Calibrator (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K854811
Methodology: https://510kreport.com/methodology