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FDA 510(k) Application Details - K093883
Device Classification Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
More FDA Info for this Device
510(K) Number
K093883
Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL, WA 98021 US
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Contact
DEBRA K HUTSON
Other 510(k) Applications for this Contact
Regulation Number
862.1100
More FDA Info for this Regulation Number
Classification Product Code
CIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2009
Decision Date
09/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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