FDA Product Code JIO: Blood, Occult, Colorimetric, In Urine
Leading manufacturers include Urit Medical Electronic Co., Ltd..
11
Total
11
Cleared
189d
Avg days
1989
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Blood, Occult, Colorimetric, In Urine Devices (Product Code JIO)
11 devices
About Product Code JIO - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code JIO since 1989, with 11 receiving FDA clearance (average review time: 189 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
JIO devices are reviewed by the Chemistry panel. Browse all Chemistry devices →