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510(k) K070727

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 by Siemens Medical Solutions Diagnostics — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2007
Date Received
March 15, 2007
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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