ACCUVETTE II
Device Facts
| Record ID | K760197 |
|---|---|
| Device Name | ACCUVETTE II |
| Applicant | Coulter Electronics, Inc. |
| Product Code | JRI · Clinical Chemistry |
| Decision Date | Jul 19, 1976 |
| 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.
