Biokit, S.A. · Class II · Cleared Mar 19, 2008
| K-number | K072036 |
| Device name | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 |
| Applicant | Biokit, S.A. |
| Product code | LEH |
| Device class | Class II |
| Decision date | Mar 19, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.3950 |
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