MYJ · Device, Mixing And Weighing, Semi-Automated
Hematology · 21 CFR 864.9195 · Class 2
Overview
| Product Code | MYJ |
|---|---|
| Device Name | Device, Mixing And Weighing, Semi-Automated |
| Regulation | 21 CFR 864.9195 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.
Classification Rationale
Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
