FDA Product Code LCP: Assay, Glycosylated Hemoglobin
Leading manufacturers include Nova Biomedical Corporation.
FDA 510(k) Cleared Assay, Glycosylated Hemoglobin Devices (Product Code LCP)
About Product Code LCP - Regulatory Context
510(k) Submission Activity
249 total 510(k) submissions under product code LCP since 1978, with 249 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under LCP have taken an average of 931 days to reach a decision - up from 143 days historically. Manufacturers should account for longer review timelines in current project planning.
LCP devices are reviewed by the Chemistry panel. Browse all Chemistry devices →