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510(k) K961123

ALT INCORPORATING DST by Trace Scientific , Ltd. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1996
Date Received
March 21, 1996
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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