PMA P110015S002

Device: 13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S002
Product code: PGE
Decision date: 2017-01-06
Classification: Gastric Emptying Breath Test
Generic name: Gastric Emptying Breath Test
Approval order 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).

Current openFDA PMA Record#

Device: 13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S002
Product code: PGE
Generic name: Gastric Emptying Breath Test
Decision date: 2017-01-06
Decision code: APPR
Date received: 2016-07-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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).