13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
FDA premarket approval P110015/S002 · decided 2017-01-06
Approval details
- PMA number
- P110015
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2016-07-15
- Decision date
- 2017-01-06
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- Approval of the qualification of additional service providers and the addition of a new test specification for the lyophilized egg (excipient) used in the production of the drug component of the 13C-Spirulina Gastric Emptying Breath Test (GEBT).
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