# K031101: Raichem Assayed Control Serum Level 1 & 2

- Pathway: 510(k) (Abbreviated)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 16, 2003 after 70 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
The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays..

Source page: https://510kreport.com/device/K031101
Methodology: https://510kreport.com/methodology