S/P VORTEX MIXER
Device Facts
| Record ID | K813148 |
|---|---|
| Device Name | S/P VORTEX MIXER |
| Applicant | American Dade |
| Product Code | JRQ · Clinical Chemistry |
| Decision Date | Nov 24, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
Regulatory Classification
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
