PMA P110015S004

Device: 13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S004
Product code: PGE
Decision date: 2018-07-12
Classification: Gastric Emptying Breath Test
Generic name: Gastric Emptying Breath Test
Approval order statement: Software and system upgrade to the analytical system used to test solid samples of Cairn’s drug substance. The drug is a component of the 13C-Spirulina gastric emptying breath test (GEBT).

Current openFDA PMA Record#

Device: 13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S004
Product code: PGE
Generic name: Gastric Emptying Breath Test
Decision date: 2018-07-12
Decision code: OK30
Date received: 2018-06-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Software and system upgrade to the analytical system used to test solid samples of Cairn’s drug substance. The drug is a component of the 13C-Spirulina gastric emptying breath test (GEBT).