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510(k) K891468

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT by Trace Scientific , Ltd. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1989
Date Received
March 15, 1989
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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