# K962890: Cholesterol-Incorporating  Dynamic Stab Tech (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace Scientific, Ltd.
- Decided: Sep 27, 1996 after 65 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992803: Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (1999), 0 descendants of its own
- K980667: Infinity Cholesterol Reagent (Procedure NO. 401) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K962890
Methodology: https://510kreport.com/methodology