Advanced Breath Diagnostics105 Westpark Dr Suite 150brentwood Tn 37027 Pma Numberp110015 Supplement Numbers010 Date Received05 03 2022 Decision Date06 01 2022 Product Code Pge Advisory Committee Clinical Chemistry Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Advanced Breath Diagnostics105 Westpark Dr Suite 150brentwood Tn 37027 Pma Numberp110015 Supplement Numbers010 Date Received05 03 2022 Decision Date06 01 2022 Product Code Pge Advisory Committee Clinical Chemistry Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P110015S010 ADVANCED BREATH DIAGNOSTICS105 Westpark Dr.suite 150brentwood, TN 37027 PMA NumberP110015 Supplement NumberS010 Date Received05/03/2022 Decision Date06/01/2022 Product Code PGE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT	2022-06-01