ULTRACLONE ECL-01-1100
Device Facts
| Record ID | K843579 |
|---|---|
| Device Name | ULTRACLONE ECL-01-1100 |
| Applicant | Earl-Clay Laboratories, Inc. |
| Product Code | KIR · Hematology |
| Decision Date | Oct 31, 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.
