# K993466: Wako L-Type Triglyceride Test

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Nov 9, 1999 after 27 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- 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. The FDA summary names its predicate without a number.
- (no number) Wako Triglyceride 30R: named in the summary without a submission number

## Indications for use
The results obtained by this test are used in the diagnosis and management of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K993466
Methodology: https://510kreport.com/methodology