Data / Medical devices / United States / Daxor Corporation
Daxor Corporation: FDA-registered device maker in Oak Ridge, TN, United States, 4 510(k) clearances
Daxor Corporation is registered with the FDA (registration 3003529145) in Oak Ridge, TN, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003529145
- FEI number
- 3003857949
- Address
- 107 Meco Ln, Oak Ridge, TN, United States, 37830
- Owner or operator
- DAXOR CORPORATION (2434654)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 18, 2004
- Registered through
- 2026
- Brand names listed
- BVA-100 BVA Software, BVA-100 Convenience Kit, Blood Volume Analyzer, Daxor BVA, Gamma Counter (DGX1), Max-100 Syringe, Sample Changer (SC-25), Whole Blood Cartridge
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Counter (Beta, Gamma) For Clinical Use | JJJ | 1 | Specification developer | accessdata.fda.gov |
| Device, Blood Volume Measuring | JWO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K261099 | Blood Volume Analyzer (200) | JWO | Substantially Equivalent | Daxor Corporation | accessdata.fda.gov |
| August 4, 2025 | K251087 | Blood Volume Analyzer (200) | JWO | Substantially Equivalent | Daxor Corporation | accessdata.fda.gov |
| December 22, 1997 | K970419 | DAXOR MAX100 SYRINGE (MAX100) | FMF | Substantially Equivalent | Daxor Corporation | accessdata.fda.gov |
| September 25, 1997 | K964406 | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | JWO | Substantially Equivalent | Daxor Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Container, Specimen, Non-Sterile
- All makers of Syringe, Piston
- All makers of Counter (Beta, Gamma) For Clinical Use
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated June 18, 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.