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510(k) K963734

ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS by Alko Diagnostic Corp. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1996
Date Received
August 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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