IL 703, STAT SEPARATOR
Device Facts
| Record ID | K812750 |
|---|---|
| Device Name | IL 703, STAT SEPARATOR |
| Applicant | Instrumentation Laboratory CO |
| Product Code | JRL · Clinical Chemistry |
| Decision Date | Jan 26, 1982 |
| 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.
