K-number	K163658
Device name	ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	CEW
Device class	Class II
Decision date	May 23, 2017
Decision	Substantially Equivalent
Regulation	862.1545

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View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay

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