PMA P110015S006
- Device
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Applicant
- Advanced Breath Diagnostics
- PMA number
- P110015
- Supplement
- S006
- Product code
- PGE
- Decision date
- 2019-11-25
- Classification
- Gastric Emptying Breath Test
- Generic name
- Gastric Emptying Breath Test
- Approval order statement
- Qualification of water activity meter used to analyze solid samples for the 13C-Spirulina gastric emptying breath test (GEBT).
Current openFDA PMA Record#
- Device
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Applicant
- Advanced Breath Diagnostics
- PMA number
- P110015
- Supplement
- S006
- Product code
- PGE
- Generic name
- Gastric Emptying Breath Test
- Decision date
- 2019-11-25
- Decision code
- OK30
- Date received
- 2019-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of water activity meter used to analyze solid samples for the 13C-Spirulina gastric emptying breath test (GEBT).