# K024305: Wiener Lab. Calibrator a Plus, Model 2X3 ML Cat. NR. 1918006

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Mar 18, 2003 after 84 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 Calibrator for Automated systems (C.f.a.s.): named in the summary without a submission number

## Indications for use
For the quantitative calibration of Wiener lab's clinical chemistry procedures. The "Calibrador A plus" is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K024305
Methodology: https://510kreport.com/methodology