| K-number | K052291 |
| Device name | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) |
| Applicant | Sebia |
| Product code | GKA |
| Device class | Class II |
| Decision date | Jun 27, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 864.7415 |
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