CJWClass II

Bromcresol Purple Dye-Binding, Albumin

21 CFR 862.1035 / Clinical Chemistry

CJW is the FDA product code for Bromcresol Purple Dye-Binding, Albumin, a class II device type, regulated under 21 CFR 862.1035. As of 2026-09-10, FDA records hold 18 510(k) clearances under this code, the most recent dated 2022-03-18, and one recall.

Classification record

Product code: CJW
Device name: Bromcresol Purple Dye-Binding, Albumin
Regulation: 21 CFR 862.1035
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 18
Ingested recalls: 1

Clearances, product code CJW

By decision year

18 clearances under product code CJW with a decision year between 1983 and 2022, 1986 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code CJW by decision year
Year	Clearances
1983	2
1984	1
1985	1
1986	4
1991	2
1998	2
1999	1
2000	1
2002	1
2013	1
2019	1
2022	1

Applicants with the most clearances

Product code CJW

Applicants holding the most 510(k) clearances under product code CJW
Applicant	Clearances
Abbott Medical	3
Em Diagnostic Systems, Inc.	2
A.P. Total Care, Inc.	1
Abbott Ireland Diagnostics Division	1
Abbott Mfg., Inc.	1
Biochemical Trade, Inc.	1
Boehringer Mannheim Corp.	1
Intersect Systems, Inc.	1
Quantimetrix Corp.	1
Randox Laboratories, Limited	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order