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510(k) K974784

AVL OPTI CRITICAL CARE ANALYZER by Avl Scientific Corp. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)

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