CJY · Class II · 21 CFR 862.1145

FDA Product Code CJY: Azo Dye, Calcium

Leading manufacturers include Abbott Ireland.

47
Total
47
Cleared
84d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 42d recently vs 85d historically

FDA 510(k) Cleared Azo Dye, Calcium Devices (Product Code CJY)

47 devices
1–24 of 47
Cleared Feb 10, 2025
Calcium2
K244042
Abbott Ireland
Chemistry · 42d

About Product Code CJY - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code CJY since 1976, with 47 receiving FDA clearance (average review time: 84 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under CJY have taken an average of 42 days to reach a decision - down from 85 days historically, suggesting improved FDA processing for this classification.

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