ANIMAL AND HUMAN SERA
Device Facts
| Record ID | K881287 |
|---|---|
| Device Name | ANIMAL AND HUMAN SERA |
| Applicant | Cell Culture Laboratories |
| Product Code | KIS · Hematology |
| Decision Date | Apr 5, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2800 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.
