Seppim S.A.S. · Class II · Cleared May 19, 2011
| K-number | K100547 |
| Device name | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
| Applicant | Seppim S.A.S. |
| Product code | LCP |
| Device class | Class II |
| Decision date | May 19, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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