Sysmex America, Inc. · Class II · Cleared Sep 8, 2003
| K-number | K032039 |
| Device name | IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
| Applicant | Sysmex America, Inc. |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Sep 8, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
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