# K904003: Hemochron (R) Heparin Response Test

- Pathway: 510(k) (Traditional)
- Applicant: Intensive Technology, Inc.
- Decided: Nov 29, 1990 after 92 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jun 24, 2010 · Not classified · Z-2110-2010: An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.

Source page: https://510kreport.com/device/K904003
Methodology: https://510kreport.com/methodology