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510(k) K061412

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 by Thermo Electron Corp. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2007
Date Received
May 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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