URITEST 10 URINALYSIS REAGENT STRIPS
FDA 510(k) clearance K052719 · decided 2006-12-05
Clearance details
- K-number
- K052719
- Device name
- URITEST 10 URINALYSIS REAGENT STRIPS
- Applicant
- Arj Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2006-12-05
- Days to decision
- 432 days
- Clearance type
- Traditional
- Product code
- CDM
- Device class
- 1
- Regulation number
- 862.1785
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oldsmar, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PyloPlus Urea Breath Test System (P170022/S008) | Arj Medical, Inc. | 2025-09-16 |
| PyloPlus UBT System (P170022/S005) | Arj Medical, Inc. | 2025-02-12 |
| PyloPlus® UBT System (P170022/S003) | Arj Medical, Inc. | 2024-01-11 |
| PyloPlus Urea Breath Test System (P170022/S002) | Arj Medical, Inc. | 2023-05-22 |
| PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer (P170022/S001) | Arj Medical, Inc. | 2022-11-30 |
| PyloPlus UBT System (P170022) | Arj Medical, Inc. | 2020-02-18 |