K-number	K182012
Device name	ADVIA Centaur Calcitonin (CALCT) assay
Applicant	Axis-Shield Diagnostics Limited
Product code	JKR
Device class	Class II
Decision date	Dec 21, 2018
Decision	Substantially Equivalent
Regulation	862.1140

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Calcitonin (CALCT) assay

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