STRATUS(R) AUTOMATED SAMPLE HANDLER
Device Facts
| Record ID | K911712 |
|---|---|
| Device Name | STRATUS(R) AUTOMATED SAMPLE HANDLER |
| Applicant | Baxter Healthcare Corp |
| Product Code | JQW · Clinical Chemistry |
| Decision Date | May 15, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2750 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
