The following data is part of a premarket notification filed by Seppim S.a.s. with the FDA for Elitech Clinical Systems Creatinne Pap Sl Model Crsl-0250, Clitech Clinical Systems Elical 2 Model Cali-0580, Elitech Cl.
| Device ID | K103376 |
| 510k Number | K103376 |
| Device Name: | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL |
| Classification | Enzymatic Method, Creatinine |
| 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 | JFY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-11-18 |
| Summary: | summary |