The following data is part of a premarket notification filed by Seppim S.a.s. with the FDA for Elitech Clinical Systems Phosphorus, Uric Acid Mono Sl And Urea Uv Sl Reagents.
| Device ID | K100263 |
| 510k Number | K100263 |
| Device Name: | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| 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 | CEO |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2011-05-06 |
| Summary: | summary |