CDM
9 FDA 510(k) clearances · Product code
111 daysmedian time to decision
432 days90th percentile
9clearances measured
FDA profile
- Official device name
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1785
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| ACON URINALYSIS REAGENT STRIPS (K061559) | Acon Laboratories Co. | 2006-08-11 |
| URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (K880584) | Mach Diag. C/O Wichita State University | 1988-05-31 |
| WAKO(TM) PRETEST 5A (K873366) | Wako Chemicals USA, Inc. | 1988-01-21 |
| TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (K852611) | Miles Laboratories, Inc. | 1985-09-03 |
| FITKIT I CHECKUP KIT (K821799) | Patton, Boggs & Blow | 1983-08-16 |
| FITKIT I CHECKUP KIT (K830340) | Boditestor | 1983-08-16 |
| DIA STRIPS SYSTEM (K831623) | California Immuno Diagnostic, Inc. | 1983-07-28 |
| REAGENT STRIPS FOR URINALYSIS (K790965) | Miles Laboratories, Inc. | 1979-06-28 |
Track CDM automatically
Every clearance here is in the API, with alerts when new ones post.