FDA Product Code LIG: Radioassay, Intrinsic Factor Blocking Antibody
Leading manufacturers include Beckman Coulter, Inc., Abbott Laboratories and Inova Diagnostics, 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
Cleared
May 03, 2024
Access Intrinsic Factor Ab
Beckman Coulter, Inc.
Chemistry
39d
Cleared
Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
Inova Diagnostics, Inc.
Immunology
176d
Cleared
Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
Beckman Coulter, Inc.
Chemistry
32d
Cleared
Nov 17, 1999
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
Diagnostic Products Corp.
Chemistry
50d
Cleared
Feb 03, 1999
ABBOTT ARCHITECT B12
Abbott Laboratories
Chemistry
78d
Cleared
Aug 23, 1990
IMX B12
Abbott Laboratories
Chemistry
31d
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.