ULTRACLONE ECL-01-400 CELL LINE
Device Facts
| Record ID | K841342 |
|---|---|
| Device Name | ULTRACLONE ECL-01-400 CELL LINE |
| Applicant | Earl-Clay Laboratories, Inc. |
| Product Code | KIR · Hematology |
| Decision Date | May 11, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2280 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
