PyloPlus Urea Breath Test System
FDA premarket approval P170022/S002 · decided 2023-05-22
Approval details
- PMA number
- P170022
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PyloPlus Urea Breath Test System
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Arj Medical, Inc.
- Date received
- 2023-03-21
- Decision date
- 2023-05-22
- Days to decision
- 62 days
- Decision code
- OK30
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Oldsmar, FL
- Statement
- Moving some packaging activities to another building (under same FEI#) and a vendor change for a critical kit component.
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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 |