FDA Product Code LIE: Reagent/device, Inoculum Calibration
Leading manufacturers include Beckman Coulter, Inc..
7
Total
7
Cleared
127d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Reagent/device, Inoculum Calibration Devices (Product Code LIE)
7 devices
About Product Code LIE - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code LIE since 1982, with 7 receiving FDA clearance (average review time: 127 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LIE devices are reviewed by the Microbiology panel. Browse all Microbiology devices →