FDA Product Code LIG: Radioassay, Intrinsic Factor Blocking Antibody
Leading manufacturers include Beckman Coulter, Inc..
8
Total
8
Cleared
101d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Radioassay, Intrinsic Factor Blocking Antibody Devices (Product Code LIG)
8 devices
About Product Code LIG - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code LIG since 1982, with 8 receiving FDA clearance (average review time: 101 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LIG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →