# K840677: HDL EZ-TZ3 Cholesterol Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Preventive Diagnostics Corp.
- Decided: Apr 13, 1984 after 58 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/K840677
Methodology: https://510kreport.com/methodology