JIR · Class I · 21 CFR 862.1645

FDA Product Code JIR: Indicator Method, Protein Or Albumin (urinary, Non-quant.)

38
Total
38
Cleared
146d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Indicator Method, Protein Or Albumin (urinary, Non-quant.) Devices (Product Code JIR)

38 devices
1–24 of 38
No devices found for this product code.

About Product Code JIR - Regulatory Context

510(k) Submission Activity

38 total 510(k) submissions under product code JIR since 1981, with 38 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.