# K013145: Wiener Lab. Got (Ast) UV AA. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat. NR. 1751302 and 20 * 2 ML Cat NR.

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 27, 2001 after 68 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) RANDOX AST ASAT GOT OPT. test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. GOT (AST) UV” test system is an in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Source page: https://510kreport.com/device/K013145
Methodology: https://510kreport.com/methodology