# K011953: Wiener Lab. Glicemia Enzimatica AA Models 1 X 250 ML Cat. #1400106; 4 250 ML Cat. # 1400107; Wiener Lab. Gilicemia Enzca

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Dec 21, 2001 after 183 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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) Data Medical Associates, Inc. (DMA) GLUCOSE (Oxidase) test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. Glicemia enzimatica AA” test system is intended to be used in the quantitative determination of glucoese in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of catbohydrate metabolism disorders- including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K011953
Methodology: https://510kreport.com/methodology