# K891475: Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 1, 1989 after 138 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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.
17 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981532: Lyphochek Immunoassay Plus Control (1998), 12 descendants of its own
- K043108: Liquichek Specialty Immunoassay Control (2004), 5 descendants of its own
- K110641: Fujirebio Diagnostics Vitamin D Control (2011), 1 descendant of its own
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer (2006), 1 descendant of its own
- K984594: Lyphochek Maternal Serum Control, Model 220 (1999), 1 descendant of its own

Source page: https://510kreport.com/device/K891475
Methodology: https://510kreport.com/methodology