Product code CDM
- Device name
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1785
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | Arj Medical, Inc. | 2006-12-05 |
| K061559 | ACON URINALYSIS REAGENT STRIPS | Acon Laboratories Co. | 2006-08-11 |
| K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | Mach Diag. C/O Wichita State University | 1988-05-31 |
| K873366 | WAKO(TM) PRETEST 5A | Wako Chemicals USA, Inc. | 1988-01-21 |
| K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | Miles Laboratories, Inc. | 1985-09-03 |
| K821799 | FITKIT I CHECKUP KIT | Patton, Boggs & Blow | 1983-08-16 |
| K830340 | FITKIT I CHECKUP KIT | Boditestor | 1983-08-16 |
| K831623 | DIA STRIPS SYSTEM | California Immuno Diagnostic, Inc. | 1983-07-28 |
| K790965 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1979-06-28 |
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| 10673486000498 | Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System | TECO DIAGNOSTICS | 2024-06-05 |
| 10673486000511 | Teco Diagnostics Uritek TC-201 Urine Chemistry Test System | TECO DIAGNOSTICS | 2024-06-04 |
| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 10673486000443 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-19 |
| 10673486000429 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-19 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| M220P0800123 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| M220P0800143 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 10673486000405 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000399 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000382 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000078 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |