# K945642: Agen Dimertest Gold Eia

- Pathway: 510(k) (Traditional)
- Applicant: Agen Biomedical, Ltd.
- Decided: Oct 25, 1995 after 343 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972696: IL Test D-Dimer (1997), 9 descendants of its own
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls (2009), 2 descendants of its own
- K090264: Hemosil D-Dimer HS 500, Controls (2010), 1 descendant of its own
- K050278: Hemosil D-Dimer (2005), 1 descendant of its own
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K945642
Methodology: https://510kreport.com/methodology