CAIRN DIAGNOSTICS

FDA Device Registration & Listing · Brentwood, TN, US · Registration 3010031043

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010031043
FEI Number
3009091796
Entity Name
CAIRN DIAGNOSTICS
City/State/Country
Brentwood, TN, US
Establishment Address
105 WESTPARK DR STE 150, Brentwood, TN 37027, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Advanced Breath Diagnostics, LLC (Owner Number: 10049228)
Owner / Operator Contact Address
105 Westpark Drive, Suite 150, Brentwood, TN 37027, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P110015

All Registered Proprietary Names

13C-Spirulina GEBT 13C-Spirulina Gastric Emptying Breath Test (GEBT) 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PGE Gastric Emptying Breath Test Unknown Class 3 N/A 2015-04-30

Official Correspondent

Kerry Bush

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Breath Diagnostics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011592854 Spirulina Production Facility Franklin, TN, US

Similar Registrations

Registration Number Establishment Name Location
3011592854 Spirulina Production Facility Franklin, TN, US
3031365458 WOMED SAS Montpellier Herault, FR
3009999323 STORE-ALL LOGISTICS LTD Slieverue Kilkenny, IE
3008478369 FERROSAN MEDICAL DEVICES A/S Soeborg Hovedstaden, DK
3028907862 XVIVO PERFUSION, INC. Aurora, CO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010031043. Last updated year: 2026. Please use registration number 3010031043 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.