Agen Biomedical , Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Agen Biomedical , Ltd. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Agen Biomedical , Ltd. has 6 FDA 510(k) cleared medical devices. Based in Brisbane, AU.
Historical record: 6 cleared submissions from 1988 to 1999. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Agen Biomedical , Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Agen Biomedical , Ltd.
6 devices
Cleared
Dec 14, 1999
SIMPLIFY D-DIMER, MODEL DCGK1
Hematology
75d
Cleared
May 26, 1998
DIMERTEST LATEX ASSAY
Hematology
168d
Cleared
Oct 25, 1995
AGEN DIMERTEST GOLD EIA
Hematology
343d
Cleared
Apr 12, 1991
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
Hematology
116d
Cleared
Mar 03, 1989
AGEN DIMERTEST EIA
Hematology
45d
Cleared
Aug 17, 1988
DIMERTEST(R) LATEX
Hematology
34d