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510(k) K893692

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 by Diagnostic Systems — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 16, 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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