PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
FDA premarket approval P170022/S001 · decided 2022-11-30
Approval details
- PMA number
- P170022
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Arj Medical, Inc.
- Date received
- 2022-05-04
- Decision date
- 2022-11-30
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Oldsmar, FL
- Statement
- Approval for the PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer and is indicated for The PyloPlus UBT system. The device, as modified, is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis of H. pylori infection in adults 18 years old and older. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Sp
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| URITEST 50 AND URITEST 500 URINE ANALYZER (K091472) | Arj Medical, Inc. | 2010-04-27 |
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| PYLO-PLUS (K052708) | Arj Medical, Inc. | 2006-05-01 |