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510(k) K162538

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator by Siemens Healthcare Diagnostics — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
September 12, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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