# K993468: Wako L-Type Got Test

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Dec 16, 1999 after 64 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- 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 UA 30R GOT product: named in the summary without a submission number

## Indications for use
AST/GOT: measurements are used in diagnosis and treatment of certain types of liver and heart disease.

Source page: https://510kreport.com/device/K993468
Methodology: https://510kreport.com/methodology