SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
Device Facts
| Record ID | K912827 |
|---|---|
| Device Name | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 |
| Applicant | Cala Diagnostics |
| Product Code | DKC · Clinical Toxicology |
| Decision Date | Aug 12, 1991 |
| 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.
