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510(k) K982501

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 by Alko Diagnostic Corp. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1998
Date Received
July 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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