The following data is part of a premarket notification filed by Seppim S.a.s. with the FDA for Elitech Clinical Systems Hba1c Reagent, Elitech Clincal System Hba1c Calibrator Set, Elitech Clinical.
| Device ID | K100547 |
| 510k Number | K100547 |
| Device Name: | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SEPPIM S.A.S. 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson SEPPIM S.A.S. 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Product Code | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2011-05-19 |
| Summary: | summary |