ROCHE-TDM ONLEIN(TM) CONTROLS
Device Facts
| Record ID | K946119 |
|---|---|
| Device Name | ROCHE-TDM ONLEIN(TM) CONTROLS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LAS · Clinical Toxicology |
| Decision Date | Feb 7, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
