CDMClass I

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

21 CFR 862.1785 / Clinical Chemistry

CDM is the FDA product code for Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), a class I device type, regulated under 21 CFR 862.1785. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2006-12-05, and one recall.

Classification record

Product code: CDM
Device name: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation: 21 CFR 862.1785
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 1

Clearances, product code CDM

By decision year

9 clearances under product code CDM with a decision year between 1979 and 2006, 1983 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code CDM by decision year
Year	Clearances
1979	1
1983	3
1985	1
1988	2
2006	2

Applicants with the most clearances

Product code CDM

Applicants holding the most 510(k) clearances under product code CDM
Applicant	Clearances
Miles Laboratories, Inc.	2
Acon Laboratories, Inc.	1
Arj Medical, Inc.	1
Boditestor	1
California Immuno Diagnostic, Inc.	1
Mach Diag. C/O Wichita State University	1
Patton, Boggs & Blow	1
FUJIFILM Healthcare Americas Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order