PMA P170022S002
- Device
- PyloPlus Urea Breath Test System
- Applicant
- Arj Medical, Inc.
- PMA number
- P170022
- Supplement
- S002
- Product code
- OZA
- Decision date
- 2023-05-22
- Classification
- Microbiology
- Generic name
- Test, urea adult and pediatric (breath),
- Approval order statement
- Moving some packaging activities to another building (under same FEI#) and a vendor change for a critical kit component.
Current openFDA PMA Record#
- Device
- PyloPlus Urea Breath Test System
- Applicant
- Arj Medical, Inc.
- PMA number
- P170022
- Supplement
- S002
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2023-05-22
- Decision code
- OK30
- Date received
- 2023-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving some packaging activities to another building (under same FEI#) and a vendor change for a critical kit component.