ROTOR SYSTEMS A/S-400 & LA/S-400
Device Facts
| Record ID | K850485 |
|---|---|
| Device Name | ROTOR SYSTEMS A/S-400 & LA/S-400 |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | JQC · Clinical Chemistry |
| Decision Date | Mar 12, 1985 |
| 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.
