FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
Device Facts
| Record ID | K936271 |
|---|---|
| Device Name | FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE |
| Applicant | Diagnostic Hybrids, Inc. |
| Product Code | KIR · Hematology |
| Decision Date | Aug 26, 1994 |
| 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.
