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510(k) K132638

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2014
Date Received
August 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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