Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
The Diazonium Colorimetry Urobilinogen Test is a clinical chemistry device that uses a diazonium salt-based colorimetric reaction for non-quantitative detection of urobilinogen in urine, used as a screening indicator of hepatic function and hemolytic conditions. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDM, regulated under 21 CFR 862.1785, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CDM
- Device Class
- FDA class 1
- Regulation Number
- 862.1785
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | Dec 05, 2006 | Substantially Equivalent | Arj Medical, Inc. |
| K061559 | ACON URINALYSIS REAGENT STRIPS | Aug 11, 2006 | Substantially Equivalent | Acon Laboratories Co. |
| K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | May 31, 1988 | Substantially Equivalent | Mach Diag. C/O Wichita State University |
| K873366 | WAKO(TM) PRETEST 5A | Jan 21, 1988 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | Sep 03, 1985 | Substantially Equivalent | Miles Laboratories, Inc. |
| K830340 | FITKIT I CHECKUP KIT | Aug 16, 1983 | Substantially Equivalent | Boditestor |
| K821799 | FITKIT I CHECKUP KIT | Aug 16, 1983 | Substantially Equivalent | Patton, Boggs & Blow |
| K831623 | DIA STRIPS SYSTEM | Jul 28, 1983 | Substantially Equivalent | California Immuno Diagnostic, Inc. |
| K790965 | REAGENT STRIPS FOR URINALYSIS | Jun 28, 1979 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.