Biokit, S.A. · Class II · Cleared Jun 19, 2007
| K-number | K063232 |
| Device name | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 |
| Applicant | Biokit, S.A. |
| Product code | CEW |
| Device class | Class II |
| Decision date | Jun 19, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 862.1545 |
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