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510(k) K133601

ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY by Siemens Healthcare Diagnostics, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2014
Date Received
November 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

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