# K984594: Lyphochek Maternal Serum Control, Model 220

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 2, 1999 after 36 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: 2 generations back to K891475 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981532: Lyphochek Immunoassay Plus Control, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K143379: Liquichek Maternal Serum II Control (2015), 0 descendants of its own

## Indications for use
Lyphochek Maternal Serum 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/K984594
Methodology: https://510kreport.com/methodology