FDA Product Code LAO: Enzyme Immunoassay, Methotrexate
Leading manufacturers include Roche Diagnostics Operations and ARK Diagnostics, Inc..
10
Total
10
Cleared
95d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Enzyme Immunoassay, Methotrexate Devices (Product Code LAO)
10 devices
Cleared
Feb 20, 2024
ONLINE TDM Methotrexate
Roche Diagnostics Operations
Toxicology
123d
Cleared
Dec 20, 2023
ARK Methotrexate II Assay
ARK Diagnostics, Inc.
Toxicology
166d
About Product Code LAO - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code LAO since 1978, with 10 receiving FDA clearance (average review time: 95 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LAO devices are reviewed by the Toxicology panel. Browse all Toxicology devices →