Data / Medical devices / United States / ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.
ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.: FDA-registered device maker in Tampa, FL, United States, 1 510(k) clearance and 1 PMA approval
ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC. is registered with the FDA (registration 3004577174) in Tampa, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated February 18, 2020. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004577174
- Address
- 13812 Wright Cir, Tampa, FL, United States, 33626
- Owner or operator
- ARJ MEDICAL, LLC (9078060)
- Roles
- Manufacturer
- First device listed
- February 6, 2007
- Registered through
- 2027
- Brand names listed
- PYLO PLUS, PyloPlus 13C Urea Breath Test, PyloPlus UBT System, PyloPlus Urea Breath Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Helicobacter Pylori | LYR | 1 | Manufacturer | accessdata.fda.gov |
| Test, Urea Adult And Pediatric (Breath), | OZA | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2006 | K052708 | PYLO-PLUS | LYR | Substantially Equivalent | Arj Medical, Inc. | 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 |
|---|---|---|---|---|---|---|
| February 18, 2020 | P170022 | PyloPlus UBT System | OZA | 6 | February 5, 2026 | accessdata.fda.gov |
Compare with other makers
Updated February 5, 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.