JIL · Class II · 21 CFR 862.1340

FDA Product Code JIL: Method, Enzymatic, Glucose (urinary, Non-quantitative)

Leading manufacturers include Arkray, Inc..

81
Total
81
Cleared
152d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Method, Enzymatic, Glucose (urinary, Non-quantitative) Devices (Product Code JIL)

81 devices
1–24 of 81

About Product Code JIL - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code JIL since 1977, with 81 receiving FDA clearance (average review time: 152 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

JIL devices are reviewed by the Chemistry panel. Browse all Chemistry devices →