JWO · Device, Blood Volume Measuring
Hematology · 21 CFR 864.5950 · Class 2
Overview
| Product Code | JWO |
|---|---|
| Device Name | Device, Blood Volume Measuring |
| Regulation | 21 CFR 864.5950 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | Aug 4, 2025 | SESE |
| K964406 | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | Daxor Corporation | Sep 25, 1997 | SESE |
Top Applicants
- Daxor Corporation — 2 clearances
