CJW · Class II · 21 CFR 862.1035

FDA Product Code CJW: Bromcresol Purple Dye-binding, Albumin

Leading manufacturers include Abbott Ireland Diagnostics Division.

18
Total
18
Cleared
76d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Bromcresol Purple Dye-binding, Albumin Devices (Product Code CJW)

18 devices
1–18 of 18

About Product Code CJW - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code CJW since 1983, with 18 receiving FDA clearance (average review time: 76 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

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