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510(k) K100344

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 by Siemens Healthcare Diagnostics — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2011
Date Received
February 5, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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