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510(k) K090330

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 by Siemens Healthcare Diagnostics, Inc. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2009
Date Received
February 10, 2009
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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