CRYOBIOLOGICAL FREEZER
Device Facts
| Record ID | K881465 |
|---|---|
| Device Name | CRYOBIOLOGICAL FREEZER |
| Applicant | Cryodyne Technologies, Inc. |
| Product Code | KSP · Hematology |
| Decision Date | Apr 21, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9225 |
| Device Class | Class 1 |
Regulatory Classification
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.
