KSP · Apparatus, Cell-Freezing And Reagents
Hematology · 21 CFR 864.9225 · Class 1
Overview
| Product Code | KSP |
|---|---|
| Device Name | Apparatus, Cell-Freezing And Reagents |
| Regulation | 21 CFR 864.9225 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.
Classification Rationale
Class I (general 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881465 | CRYOBIOLOGICAL FREEZER | Cryodyne Technologies, Inc. | Apr 21, 1988 | SESE |
Top Applicants
- Cryodyne Technologies, Inc. — 1 clearance
