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510(k) K972004

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS by Alko Diagnostic Corp. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
May 30, 1997
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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