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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastric Emptying Breath Test | PGE | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 6, 2015 | P110015 | GASTRIC EMPTYING BREATH TEST (GEBT) | PGE | 10 | April 24, 2026 | accessdata.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.