# K895905: Lyphochek Whole Blood Control (Human) Levels 1,2,3

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 18, 1990 after 104 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K980871: Lyphochek Whole Blood Control (1998), 9 descendants of its own
- K022041: Lyphochek Whole Blood Control, Models 561, 562, 563 (2002), 6 descendants of its own
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (2007), 2 descendants of its own
- K984477: Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 (1999), 1 descendant of its own
- K132174: Multichem WBT (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K895905
Methodology: https://510kreport.com/methodology