LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
Device Facts
| Record ID | K891691 |
|---|---|
| Device Name | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II |
| Applicant | Bio-Rad |
| Product Code | DIE · Clinical Toxicology |
| Decision Date | Dec 19, 1989 |
| 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.
