# K905405: Chemtrak Accumeter Cholesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Chemtrak, Inc.
- Decided: Mar 19, 1991 after 106 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K960377: Ena-C-T Total Cholesterol Test (1996), 1 descendant of its own
- K981181: Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) (1998), 0 descendants of its own
- K960378: Ena-C-T Assayed Total Cholesterol Controls (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K905405
Methodology: https://510kreport.com/methodology