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510(k) K974003

ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 by Diagnostic Chemicals , Ltd. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1997
Date Received
October 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

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