13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
FDA premarket approval P110015/S011 · decided 2025-07-21
Approval details
- PMA number
- P110015
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2025-01-24
- Decision date
- 2025-07-21
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- approval for a manufacturing site located at Spirulina Production Facility (also known as API ProductionFacility), 318 Seaboard Lane, Suite 313, Franklin, TN 37067, USA, for lyophilization of 13C-Spirulina
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