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510(k) K033055

GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS by Diamond Diagnostics, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
September 29, 2003
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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