PRE-DENT
Device Facts
| Record ID | K791200 |
|---|---|
| Device Name | PRE-DENT |
| Applicant | Fichte, Graves, and Hunt |
| Product Code | GIM · Clinical Chemistry |
| Decision Date | Aug 10, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
