Agen Biomedical , Ltd.
Medical device manufacturer in Brisbane, Queensland, AU.
6510(k) clearances
0PMA approvals
0recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | 12/14/1999SE |
| K974596 | Dimertest Latex AssayDAP · Traditional | 05/26/1998SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | 10/25/1995SE |
| K905643 | Bed Red D-Dimer Whole Blood Agglutination AssayGHH · Traditional | 04/12/1991SE |
| K890189 | Agen Dimertest EiaDAP · Traditional | 03/03/1989SE |
| K882944 | Dimertest(R) LatexDAP · Traditional | 08/17/1988SE |