PMA P110015S007

Device: 13 C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S007
Product code: PGE
Decision date: 2021-03-16
Generic name: Gastric Emptying Breath Test
Approval order statement: Changes to the quality control process used during the manufacture of the 13C-Spirulina substrate. The substrate is a component of the GEBT.

Current openFDA PMA Record#

Device: 13 C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant: Advanced Breath Diagnostics
PMA number: P110015
Supplement: S007
Product code: PGE
Generic name: Gastric Emptying Breath Test
Decision date: 2021-03-16
Decision code: OK30
Date received: 2021-02-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the quality control process used during the manufacture of the 13C-Spirulina substrate. The substrate is a component of the GEBT.