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510(k) K041478

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR by Becton Dickinson — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2004
Date Received
June 3, 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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