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510(k) K023551

WIENER LAB GOT (AST) UV AA LIQUIDA by Wiener Laboratories Saic — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2002
Date Received
October 22, 2002
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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