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510(k) K993837

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1999
Date Received
November 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER (November 29, 1996)
  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)

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