# K972209: Spectrolyse Heparin (Anti-Iia)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Diagnostic Technologies, Inc.
- Decided: Aug 12, 1997 after 62 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013637: Actichrome Heparin (Anti-Fiia) (2002), 0 descendants of its own

## Indications for use
Spectrolyse® Heparin (anti-1la) is intended for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma by anti-l| activity.

Source page: https://510kreport.com/device/K972209
Methodology: https://510kreport.com/methodology