- Device
- 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
- Applicant
- Advanced Breath Diagnostics
- PMA number
- P110015
- Supplement
- S010
- Product code
- PGE
- Generic name
- Gastric Emptying Breath Test
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the quality control testing of the 13C-Spirulina/Egg Mix. The 13C-Spirulina/Egg Mix is a component of the 13C-Spirulina Gastric Emptying Breath Test (GEBT).