Medical Device Manufacturer · AU , Brisbane

Agen Biomedical , Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1988

Recent clearances: SIMPLIFY D-DIMER, MODEL DCGK1, DIMERTEST LATEX ASSAY

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Agen Biomedical , Ltd. Hematology ✕

6 devices

1-6 of 6

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