Data / Medical devices / United States / ELITechGroup Inc., Tucson
ELITechGroup Inc., Tucson: FDA-registered device maker in Tucson, AZ, United States, 1 510(k) clearance
ELITechGroup Inc., Tucson is registered with the FDA (registration 3044320359) in Tucson, AZ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044320359
- Address
- 3950 S. Country Club Rd. Suite #470, L, Tucson, AZ, United States, 85714
- Owner or operator
- ELITechGroup Inc. (1717966)
- Roles
- Manufacturer
- First device listed
- March 20, 2026
- Registered through
- 2026
- Brand names listed
- Bruker Arc Blood Culture Kit, Bruker Arc System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mass Spectrometry, Microorganism Identification, Blood Culture | QNJ | 2 | 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 |
|---|---|---|---|---|---|---|
| September 26, 2024 | K240854 | Accelerate Arc System | QNJ | Substantially Equivalent | Accelerate Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 26, 2024. 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.