ONE DRAM SHELL VIAL, CATALOG #02-111
Device Facts
| Record ID | K930373 |
|---|---|
| Device Name | ONE DRAM SHELL VIAL, CATALOG #02-111 |
| Applicant | Proteins Intl., Inc. |
| Product Code | KIR · Hematology |
| Decision Date | Mar 23, 1993 |
| 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.