Wallac OY · Class II · Cleared Mar 8, 2006
| K-number | K050709 |
| Device name | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 |
| Applicant | Wallac OY |
| Product code | GKA |
| Device class | Class II |
| Decision date | Mar 8, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 864.7415 |
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