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510(k) K041427

THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS by Arkray, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
May 28, 2004
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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