13C-Spirulina Gastric Emptying Breath Test (GEBT)
FDA premarket approval P110015/S006 · decided 2019-11-25
Approval details
- PMA number
- P110015
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2019-10-30
- Decision date
- 2019-11-25
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- Qualification of water activity meter used to analyze solid samples for the 13C-Spirulina gastric emptying breath test (GEBT).
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