KSH · Chamber, Environmental For The Storage Of Platelet Concentrate
Hematology · 21 CFR 864.9575 · Class 2
Overview
| Product Code | KSH |
|---|---|
| Device Name | Chamber, Environmental For The Storage Of Platelet Concentrate |
| Regulation | 21 CFR 864.9575 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Special Controls
*Classification.* Class II (special controls). The 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.
