Company ยท AU
Agen Biomedical , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1999. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 1999 | K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 Agen Biomedical , Ltd., AU | GHH |
| May 26, 1998 | K974596 | DIMERTEST LATEX ASSAY Agen Biomedical , Ltd., AU | DAP |
| Oct 25, 1995 | K945642 | AGEN DIMERTEST GOLD EIA Agen Biomedical , Ltd., AU | GHH |
| Apr 12, 1991 | K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY Agen Biomedical , Ltd., AU | GHH |
| Mar 3, 1989 | K890189 | AGEN DIMERTEST EIA Agen Biomedical , Ltd. | DAP |
| Aug 17, 1988 | K882944 | DIMERTEST(R) LATEX Agen Biomedical , Ltd., AU | DAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||