Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
FDA product code CDM · Class I (low risk) · 21 CFR 862.1785 · Clinical Chemistry
9510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052719 | Uritest 10 Urinalysis Reagent StripsCDM · Traditional | Arj Medical, Inc. | 12/05/2006SE |
| K061559 | Acon Urinalysis Reagent StripsCDM · Traditional | Acon Laboratories Co. | 08/11/2006SE |
| K880584 | Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8CCDM · Traditional | Mach Diag. C/O Wichita State University | 05/31/1988SE |
| K873366 | Wako(Tm) Pretest 5ACDM · Traditional | Wako Chemicals USA, Inc. | 01/21/1988SE |
| K852611 | Test Urobilinogen in Urine & Leukocytes in UrineCDM · Traditional | Miles Laboratories, Inc. | 09/03/1985SE |
| K830340 | Fitkit I Checkup KitCDM · Traditional | Boditestor | 08/16/1983SE |
| K821799 | Fitkit I Checkup KitCDM · Traditional | Patton, Boggs & Blow | 08/16/1983SE |
| K831623 | Dia Strips SystemCDM · Traditional | California Immuno Diagnostic, Inc. | 07/28/1983SE |
| K790965 | Reagent Strips for UrinalysisCDM · Traditional | Miles Laboratories, Inc. | 06/28/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2786-2018 Class III | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG…Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the… | Clarity Diagnostics Llc | 06/22/2018Terminated |