Diazyme Laboratories · Class II · Cleared Feb 1, 2008
| K-number | K072270 |
| Device name | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) |
| Applicant | Diazyme Laboratories |
| Product code | NDY |
| Device class | Class II |
| Decision date | Feb 1, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.1225 |
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