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510(k) K082030

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 by Siemens Healthcare Diagnostics, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2008
Date Received
July 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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