# K032074: Linical Esoterics Calibration Verifiers Levels a-E for Beckman Coulter Synchron Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Oct 21, 2003 after 106 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 LiniCALTuEsoterics Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron@Analyzers. Five assayed levels of AMM (ammonia), ETOH (alcohol), MA (microalbumin), M-TP (microprotein) and SALY (salicylate) are provided to allow monitoring of the reportable range.

Source page: https://510kreport.com/device/K032074
Methodology: https://510kreport.com/methodology