# K022767: Raichem Lipid Calibrator

- Pathway: 510(k) (Special)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Sep 3, 2002 after 13 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.

Source page: https://510kreport.com/device/K022767
Methodology: https://510kreport.com/methodology