FDA Product Code LIO: Device, Specimen Collection
Leading manufacturers include Arx Sciences, Inc..
63
Total
63
Cleared
86d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Device, Specimen Collection Devices (Product Code LIO)
63 devices
About Product Code LIO - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code LIO since 1982, with 63 receiving FDA clearance (average review time: 86 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LIO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →