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510(k) K083465

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2009
Date Received
November 24, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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