The following data is part of a premarket notification filed by Elitechgroup Seppim S.a.s. with the FDA for Elitech Clincal Systems Cholesterol Hdl Sl 2g, Hdl 2g Calibrator, Ldl Sl 2g, Ldl 2g Calibrator, Elitrol Ii & Elitech Sys.
| Device ID | K103747 |
| 510k Number | K103747 |
| Device Name: | ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | ELITECHGROUP SEPPIM S.A.S. 21720 23RD DR SE, SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECHGROUP SEPPIM S.A.S. 21720 23RD DR SE, SUITE 150 Bothell, WA 98021 |
| Product Code | LBS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-08-31 |
| Summary: | summary |