CIX · Class II · 21 CFR 862.1035

FDA Product Code CIX: Bromcresol Green Dye-binding, Albumin

Leading manufacturers include Truvian Health.

120
Total
120
Cleared
74d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 269d recently vs 72d historically

FDA 510(k) Cleared Bromcresol Green Dye-binding, Albumin Devices (Product Code CIX)

120 devices
1–24 of 120
Cleared Jan 09, 2026
Core Metabolic
K251157
Truvian Health
Chemistry · 269d

About Product Code CIX - Regulatory Context

510(k) Submission Activity

120 total 510(k) submissions under product code CIX since 1976, with 120 receiving FDA clearance (average review time: 74 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 CIX have taken an average of 269 days to reach a decision - up from 72 days historically. Manufacturers should account for longer review timelines in current project planning.

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