13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
FDA premarket approval P110015/S010 · decided 2022-06-01
Approval details
- PMA number
- P110015
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2022-05-03
- Decision date
- 2022-06-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- 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).
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