The following data is part of a premarket notification filed by Seppim S.a.s. with the FDA for Ast/got 4+1 Sl, Ast/got 4+1 Sl, Elical 2, Elitrol I, Elitrol Ii, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont-.
| Device ID | K093883 |
| 510k Number | K093883 |
| Device Name: | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-09-20 |
| Summary: | summary |