CEA-IMMERSIBLE SEPARATOR
Device Facts
| Record ID | K781043 |
|---|---|
| Device Name | CEA-IMMERSIBLE SEPARATOR |
| Applicant | Millipore Corp. |
| Product Code | JRL · Clinical Chemistry |
| Decision Date | Sep 15, 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.
