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510(k) K090900

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 by Siemens Healthcare Diagnostics — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2009
Date Received
April 1, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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