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510(k) K093883

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- by Seppim S.A.S. — Product Code CIT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 20, 2010
Date Received: December 18, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class: Class II
Regulation Number: 862.1100
Review Panel: CH
Submission Type

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