# K925433: The Stachrom Heparin Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: May 23, 1995 after 937 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K013305: Enoxaparin Test Card (2002), 0 descendants of its own
- K965076: Mda Heparin Anti-X Assay (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K925433
Methodology: https://510kreport.com/methodology