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510(k) K897165

COULTER AST (GOT) REAGENT by Coulter Electronics, Inc. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1990
Date Received
December 28, 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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