# K013332: Linical Protein I Calibration Verifiers Levels a=E for Beckman Coulter Immage

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Nov 20, 2001 after 42 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
LiniCAL™ Protein | Calibration Verifiers Levels A — E for Beckman Coulter Immage™ is intended for use as an assayed quality control material for analysis.

Source page: https://510kreport.com/device/K013332
Methodology: https://510kreport.com/methodology