# K934046: Beckman Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman-Diagnostic Systems Group
- Decided: Oct 28, 1993 after 70 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System (2002), 1 descendant of its own
- K063852: Accessa Cholesterol Panel (2007), 0 descendants of its own
- K011970: Biosafe Cholesterol Profile Blood Collection and Transport System (2001), 0 descendants of its own
- K971505: Synchron Systems Cholesterol (Chol) Reagent (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K934046
Methodology: https://510kreport.com/methodology