13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
FDA premarket approval P110015/S004 · decided 2018-07-12
Approval details
- PMA number
- P110015
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2018-06-14
- Decision date
- 2018-07-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- Statement
- Software and system upgrade to the analytical system used to test solid samples of Cairns drug substance. The drug is a component of the 13C-Spirulina gastric emptying breath test (GEBT).
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