FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella
Leading manufacturers include Abbott Laboratories and Beckman Coulter, Inc..
FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Rubella Devices (Product Code LFX)
About Product Code LFX - Regulatory Context
510(k) Submission Activity
94 total 510(k) submissions under product code LFX since 1979, with 94 receiving FDA clearance (average review time: 172 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LFX have taken an average of 263 days to reach a decision - up from 170 days historically. Manufacturers should account for longer review timelines in current project planning.
LFX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →