Advanced Breath Diagnostics L L C

FDA Filings

This page includes the latest FDA filings for Advanced Breath Diagnostics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011592854
• FEI Number: 3010484784
• Name: Spirulina Production Facility
• Owner & Operator: Advanced Breath Diagnostics, LLC
• Contact Address: 105 Westpark Drive Suite 150; Brentwood TN 37027 US
• Official Correspondent:
  • Kerry Bush
  • 1-615-3765464-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 318 Seaboard Lane Suite 313; Franklin, TN 37067 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3010031043
• FEI Number: 3009091796
• Name: CAIRN DIAGNOSTICS
• Owner & Operator: Advanced Breath Diagnostics, LLC
• Contact Address: 105 Westpark Drive Suite 150; Brentwood TN 37027 US
• Official Correspondent:
  • Kerry Bush
  • 1-615-3765464-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 105 WESTPARK DR STE 150 ; Brentwood, TN 37027 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID M763K0211 ADVANCED BREATH DIAGNOSTICS, LLC	13C-Spirulina GEBT	2021-02-19
PMN P110015 | PGE Spirulina Production Facility [Advanced Breath Diagnostics, LLC]	Gastric Emptying Breath Test (GEBT)	2015-04-30
PMN P110015 | PGE Spirulina Production Facility [Advanced Breath Diagnostics, LLC]	13C-Spirulina	2015-04-30
PMN P110015 | PGE Spirulina Production Facility [Advanced Breath Diagnostics, LLC]	13C-Spirulina Gastric Emptying Breath Test (GEBT)	2015-04-30
PMN P110015 | PGE Spirulina Production Facility [Advanced Breath Diagnostics, LLC]	13C-Spirulina GEBT	2015-04-30
PMN P110015 | PGE CAIRN DIAGNOSTICS [Advanced Breath Diagnostics, LLC]	Gastric Emptying Breath Test (GEBT)	2015-04-30
PMN P110015 | PGE CAIRN DIAGNOSTICS [Advanced Breath Diagnostics, LLC]	13C-Spirulina	2015-04-30
PMN P110015 | PGE CAIRN DIAGNOSTICS [Advanced Breath Diagnostics, LLC]	13C-Spirulina Gastric Emptying Breath Test (GEBT)	2015-04-30
PMN P110015 | PGE CAIRN DIAGNOSTICS [Advanced Breath Diagnostics, LLC]	13C-Spirulina GEBT	2015-04-30

Similar & Related FDA Registered Companies

• 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