# K033162: Linical Chemistry Calibration Verifiers Levels a-E for Olympus AU Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Oct 10, 2003 after 10 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CLlNlQA LiniCALTMChemistry Calibration Verifiers Levels A - E for Olympus AU Systems” are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU SystemsTM for Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations.

Source page: https://510kreport.com/device/K033162
Methodology: https://510kreport.com/methodology