Submission Details
| 510(k) Number | K093883 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2009 |
| Decision Date | September 20, 2010 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
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-
Sep 2010
Decision
276d
Days
Class 2
Risk
About This 510(k) Submission
K093883 is an FDA 510(k) clearance for the 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-, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on September 20, 2010, 276 days after receiving the submission on December 18, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.
Device Classification
| Product Code | CIT — Nadh Oxidation/nad Reduction, Ast/sgot |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1100 |
Manufacturer
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