PMA P110015S012

Device: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S012
Product code: PGE
Decision date: 2026-04-24
Classification: Clinical Chemistry
Generic name: Gastric Emptying Breath Test
Approval order statement: approval for a manufacturing site located at Spirulina Production Facility, 318 Seaboard Lane, Suite 313, Franklin, TN 37067, USA, for packaging of the 13C-Spirulina/Egg Mix, finished device assembly and distribution operations of the 13C-Spirulina GEBT kit.

Current openFDA PMA Record#

Device: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S012
Product code: PGE
Generic name: Gastric Emptying Breath Test
Decision date: 2026-04-24
Decision code: APPR
Date received: 2025-08-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Spirulina Production Facility, 318 Seaboard Lane, Suite 313, Franklin, TN 37067, USA, for packaging of the 13C-Spirulina/Egg Mix, finished device assembly and distribution operations of the 13C-Spirulina GEBT kit.