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Data / Medical devices / United States / Spirulina Production Facility

Spirulina Production Facility: FDA-registered device maker in Franklin, TN, United States, 1 PMA approval

Spirulina Production Facility is registered with the FDA (registration 3011592854) in Franklin, TN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 6, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011592854
FEI number
3010484784
Address
318 Seaboard Lane Suite 313, Franklin, TN, United States, 37067
Owner or operator
Advanced Breath Diagnostics, LLC (10049228)
Roles
Manufacturer
First device listed
April 30, 2015
Registered through
2026
Brand names listed
13C-Spirulina, 13C-Spirulina GEBT, 13C-Spirulina Gastric Emptying Breath Test (GEBT), Gastric Emptying Breath Test (GEBT)

Devices it lists

DeviceProduct codeClassRoleSource
Gastric Emptying Breath TestPGE3Manufactureraccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 6, 2015P110015GASTRIC EMPTYING BREATH TEST (GEBT)PGE10April 24, 2026accessdata.fda.gov

Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.