Blood Volume Analyzer (200)— 510(k) K261099
Substantially EquivalentDaxor Corporation
FDA 510(k) clearance K261099 for Blood Volume Analyzer (200), Substantially Equivalent on 2026-06-18. Applicant: Daxor Corporation. Device class: 2.
Summary
Daxor's Blood Volume Analyzer (200) is filed under JWO, blood volume measuring devices. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 864.5950. Hematology is both the classification panel and the review panel, and it came in as a Special 510(k).
Daxor filed from Oak Ridge, Tennessee. Review took 77 calendar days (April 2 to June 18, 2026).
Clearance details
- Applicant
- Daxor Corporation
- Product code
- Product code JWO
- Device class
- Class 2
- Regulation
- 21 CFR 864.5950
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Oak Ridge, TN, US
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