Agen Biomedical , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993276SIMPLIFY D-DIMER, MODEL DCGK1December 14, 1999
K974596DIMERTEST LATEX ASSAYMay 26, 1998
K945642AGEN DIMERTEST GOLD EIAOctober 25, 1995
K905643BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYApril 12, 1991
K890189AGEN DIMERTEST EIAMarch 3, 1989
K882944DIMERTEST(R) LATEXAugust 17, 1988