Blood Volume Analyzer (200)

by Daxor Corporation 510(k)

Active United States

510(k) K261099

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK261099	Date18 Jun 2026Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K261099
FDA Product Code: JWO

Device Class: Class II
Regulation: 21 CFR Part 864.5950
Advisory Committee: Hematology
FDA Decision: SESE Substantially Equivalent

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