# K862386: Ics Apolipoprotein B Reagent Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jul 18, 1986 after 24 days
- Product code: MSJ (Apolipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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
- K970314: Synchron LX Systems Apolipoprotein (Apoa and Apob) Reagents (1997), 0 descendants of its own
- K964010: Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry System Apolipoprotein B Reagent (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K862386
Methodology: https://510kreport.com/methodology