# K992741: Lyphochek Anemia Control, Model 500

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 9, 1999 after 85 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
Longest line of descent: 1 generation back to K812635 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812635: Anemia Control, Environmental Chemical Specialties (1981) Summary page 1.

## Indications for use
Lyphochek Anemia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert

Source page: https://510kreport.com/device/K992741
Methodology: https://510kreport.com/methodology