PRE-DENT SYSTEM
Device Facts
| Record ID | K800736 |
|---|---|
| Device Name | PRE-DENT SYSTEM |
| Applicant | Pre-Dent System |
| Product Code | KSS · Hematology |
| Decision Date | Apr 24, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9050 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
