# K812424: CI-Trol Heparin Controls, Low/High

- Pathway: 510(k) (Traditional)
- Applicant: American Dade
- Decided: Oct 2, 1981 after 39 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042941: Dade Behring Heparin Calibrator and Controls (2004), 2 descendants of its own
- K083175: Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin UF Control 2 (2009), 0 descendants of its own
- K051472: Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K812424
Methodology: https://510kreport.com/methodology