FDA.reportPublic FDA data

PMA P110015S009

Device
13C-Spirulina Gastric Emptying Breath Test (GEBT)
Applicant
Advanced Breath Diagnostics
Product code
PGE
Decision date
2023-05-19
Generic name
Gastric Emptying Breath Test
Approval order statement
Approval for the addition of an updated model of Gas Isotope Ratio Mass Spectrometer (GIRMS) for use in analyzing 13C/12C ratios in breath samples as part of your approved 13C-Spirulina 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
S009
Product code
PGE
Generic name
Gastric Emptying Breath Test
Decision date
2023-05-19
Decision code
APPR
Date received
2021-10-20
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of an updated model of Gas Isotope Ratio Mass Spectrometer (GIRMS) for use in analyzing 13C/12C ratios in breath samples as part of your approved 13C-Spirulina Gastric Emptying Breath Test (GEBT)