13C-Spirulina Gastric Emptying Breath Test (GEBT)
FDA premarket approval P110015/S008 · decided 2021-08-10
Approval details
- PMA number
- P110015
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2021-03-16
- Decision date
- 2021-08-10
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- Approval for a change to labeling that will facilitate telehealth administration of the device.
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