PYLO-PLUS
FDA 510(k) clearance K052708 · decided 2006-05-01
Clearance details
- K-number
- K052708
- Device name
- PYLO-PLUS
- Applicant
- Arj Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2006-05-01
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.
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 |