CDM — Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Class I
FDA product code CDM covers "Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)", a Class I medical device regulated under 21 CFR 862.1785. Submissions are reviewed by the Clinical Chemistry panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CDM
- Device Class
- Class I
- Regulation Number
- 862.1785
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052719 | arj medical | URITEST 10 URINALYSIS REAGENT STRIPS | December 5, 2006 |
| K061559 | acon laboratories | ACON URINALYSIS REAGENT STRIPS | August 11, 2006 |
| K880584 | mach diag. c/o wichita state university | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | May 31, 1988 |
| K873366 | wako chemicals usa | WAKO(TM) PRETEST 5A | January 21, 1988 |
| K852611 | miles laboratories | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | September 3, 1985 |
| K830340 | boditestor | FITKIT I CHECKUP KIT | August 16, 1983 |
| K821799 | patton, boggs and blow | FITKIT I CHECKUP KIT | August 16, 1983 |
| K831623 | california immuno diagnostic | DIA STRIPS SYSTEM | July 28, 1983 |
| K790965 | miles laboratories | REAGENT STRIPS FOR URINALYSIS | June 28, 1979 |