ENZAC INCUBATOR
Device Facts
| Record ID | K781501 |
|---|---|
| Device Name | ENZAC INCUBATOR |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | JRG · Clinical Chemistry |
| Decision Date | Oct 3, 1978 |
| 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.
