SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
Device Facts
| Record ID | K893811 |
|---|---|
| Device Name | SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM |
| Applicant | Sakura Finetek U.S.A., Inc. |
| Product Code | JQW · Clinical Chemistry |
| Decision Date | Sep 7, 1989 |
| 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.