Diazyme Laboratories · Class I · Cleared Mar 7, 2008
| K-number | K073488 |
| Device name | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
| Applicant | Diazyme Laboratories |
| Product code | MSJ |
| Device class | Class I |
| Decision date | Mar 7, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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