# K935212: IL Test Heparin (XA), PN 84699-15

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 7, 1994 after 101 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K980242: IL Test Heparin (1998), 7 descendants of its own
- K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls (2009), 4 descendants of its own
- K213464: HemosIL Liquid Anti-Xa (2022), 2 descendants of its own
- K223187: HemosIL Liquid Anti-Xa (2023), 1 descendant of its own
- K983178: Coamatic Heparin (1998), 1 descendant of its own

Source page: https://510kreport.com/device/K935212
Methodology: https://510kreport.com/methodology