PMA P110015S005

Device: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S005
Product code: PGE
Decision date: 2019-08-29
Classification: Gastric Emptying Breath Test
Generic name: Gastric Emptying Breath Test
Approval order statement: Approval for changing the manufacturing site for the unit dose packaged 13C-Spirulina/egg mix that constitutes the diagnostic drug product in the Gastric Emptying Breath Test (GEBT).

Current openFDA PMA Record#

Device: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S005
Product code: PGE
Generic name: Gastric Emptying Breath Test
Decision date: 2019-08-29
Decision code: APPR
Date received: 2019-03-05
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing the manufacturing site for the unit dose packaged 13C-Spirulina/egg mix that constitutes the diagnostic drug product in the Gastric Emptying Breath Test (GEBT).