# Agen Biomedical, Ltd.

- Location (FDA's records): Brisbane, AU
- FDA decisions: 6 (1988–1999): 6 510(k) clearances
- Product codes: DAP (3), GHH (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- American Diagnostica, Inc.: 1 (https://510kreport.com/company/american-diagnostica)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Organon Teknika Corp.: 1 (https://510kreport.com/company/organon-teknika)

## Its most-cited devices
- K945642: Agen Dimertest Gold Eia (1995), cited by 2
- K882944: Dimertest (R) Latex (1988), cited by 1

## Recent decisions
- K993276: Simplify D-Dimer, Model DCGK1 (Dec 14, 1999)
- K974596: Dimertest Latex Assay (May 26, 1998)
- K945642: Agen Dimertest Gold Eia (Oct 25, 1995)
- K905643: Bed Red D-Dimer Whole Blood Agglutination Assay (Apr 12, 1991)
- K890189: Agen Dimertest Eia (Mar 3, 1989)
- K882944: Dimertest (R) Latex (Aug 17, 1988)

Source page: https://510kreport.com/company/agen-biomedical