# K013095: Wiener Lab.Fosfatemia UV, Models 1X100 ML Cat.N 1382321, 4X20 ML Cat.N 1009311

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 16, 2001 after 60 days
- Product code: CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus)
- Device class: 1
- Regulation: 21 CFR 862.1580
- 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) ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system (Cat. N° 836281): named in the summary without a submission number

## Indications for use
The “Wiener lab. Fosfatemia UV AA” test system is a quantitative in vitro diagnostic device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Source page: https://510kreport.com/device/K013095
Methodology: https://510kreport.com/methodology