# K040091: Linical Esoterics Calibration Verifiers Levels a-E for Olympus AU Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Feb 23, 2004 after 38 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
CLINIQA LiniCAL TM Esoterics Calibration Verifiers Levels A - E for Olympus AU Systems T M are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems TM for Ammonia, Ethanol, Microalbumin, Salicylate, and Urinary/CSF Protein at five useful concentrations.

Source page: https://510kreport.com/device/K040091
Methodology: https://510kreport.com/methodology