21 CFR 864.9575 — Chamber, Environmental For The Storage Of Platelet Concentrate
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9575
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSH | Chamber, Environmental For The Storage Of Platelet Concentrate | 2 | 0 |
Special Controls
KSH — Chamber, Environmental For The Storage Of Platelet Concentrate
*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.
eCFR
