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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) 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-
Applicant
Seppim S.A.S.
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
Seppim S.A.S.
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1100
Classification Product Code
CIT  
Subsequent Product Codes
JIT   JJE   JJX  
Date Received12/18/2009
Decision Date 09/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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