# K011112: Cyclosporine Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 17, 2001 after 97 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K052015: Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108 (2005), 3 descendants of its own
- K053108: Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108 (2006), 2 descendants of its own
- K061503: Dimension Cyclosporine Extended Range Calibrator (DC108A) (2006), 1 descendant of its own
- K082030: Dimension Vista Csae Calibrator, Model KC440 (2008), 0 descendants of its own
- K062199: Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430) (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K011112
Methodology: https://510kreport.com/methodology