GENESIS RMP
Device Facts
| Record ID | K963268 |
|---|---|
| Device Name | GENESIS RMP |
| Applicant | Tecan U.S., Inc. |
| Product Code | JRA · Clinical Chemistry |
| Decision Date | Mar 18, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2680 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.