13C-Spirulina Gastric Emptying Breath Test (GEBT)
FDA premarket approval P110015/S009 · decided 2023-05-19
Approval details
- PMA number
- P110015
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2021-10-20
- Decision date
- 2023-05-19
- Days to decision
- 576 days
- Decision code
- APPR
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- Approval for the addition of an updated model of Gas Isotope Ratio Mass Spectrometer (GIRMS) for use in analyzing 13C/12C ratios in breath samples as part of your approved 13C-Spirulina Gastric Emptying Breath Test (GEBT)
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