PMA P110015S008
- Device
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Applicant
- Advanced Breath Diagnostics
- PMA number
- P110015
- Supplement
- S008
- Product code
- PGE
- Decision date
- 2021-08-10
- Generic name
- Gastric Emptying Breath Test
- Approval order statement
- Approval for a change to labeling that will facilitate telehealth administration of the device.
Current openFDA PMA Record#
- Device
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Applicant
- Advanced Breath Diagnostics
- PMA number
- P110015
- Supplement
- S008
- Product code
- PGE
- Generic name
- Gastric Emptying Breath Test
- Decision date
- 2021-08-10
- Decision code
- APPR
- Date received
- 2021-03-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to labeling that will facilitate telehealth administration of the device.