# K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 11, 1996 after 29 days
- Product code: JJT (Enzyme 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.
20 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K903430: Liquichek CK/LD Isoenzyme Control; Levels 1 and 2, Bio-Rad (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K980556: Liquichek Cardiac Markers Control LT (1998), 14 descendants of its own
- K012656: Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 (2001), 13 descendants of its own
- K021498: Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel (2002), 12 descendants of its own
- K040277: Liquichek Cardiac Marker Control LT (2004), 11 descendants of its own
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus (2005), 8 descendants of its own

## Indications for use
Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s specific cardiac marker procedures.

Source page: https://510kreport.com/device/K961828
Methodology: https://510kreport.com/methodology