H292
Device Facts
| Record ID | K942820 |
|---|---|
| Device Name | H292 |
| Applicant | Bartels, Inc. |
| Product Code | KIR · Hematology |
| Decision Date | May 5, 1995 |
| 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.
