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510(k) K042767

DATAPRO CLINICAL CHELISTRY ANALYZER by Thermo Electron Corporation — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2005
Date Received
October 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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