The following data is part of a premarket notification filed by Seppim S.a.s. with the FDA for Elitech Clinical Systems Glucose Pap Sl Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 And 2.
| Device ID | K100525 |
| 510k Number | K100525 |
| Device Name: | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SEPPIM S.A.S. 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Contact | Debra Hutson |
| Correspondent | Debra Hutson SEPPIM S.A.S. 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Product Code | CGA |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-24 |
| Decision Date | 2010-12-15 |
| Summary: | summary |