# K013983: Wiener Lab. Alp 405

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Jan 28, 2002 after 56 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- 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 ALKALINE PHOSPHATASE OPT. test system (Cat. N° AP307): named in the summary without a submission number

## Indications for use
The “Wiener lab. ALP 405" test system is an in vitro diagnostic device intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparinized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K013983
Methodology: https://510kreport.com/methodology