PMA P170022S008
- Device
- PyloPlus Urea Breath Test System
- Applicant
- Arj Medical, Inc.
- PMA number
- P170022
- Supplement
- S008
- Product code
- OZA
- Decision date
- 2025-09-16
- Classification
- Microbiology
- Generic name
- Test, urea adult and pediatric (breath),
- Approval order statement
- consolidation of all manufacturing activities to a single location and to increase a manufacturing maximum batch size
Current openFDA PMA Record#
- Device
- PyloPlus Urea Breath Test System
- Applicant
- Arj Medical, Inc.
- PMA number
- P170022
- Supplement
- S008
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2025-09-16
- Decision code
- OK30
- Date received
- 2025-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- consolidation of all manufacturing activities to a single location and to increase a manufacturing maximum batch size