K-number	K172133
Device name	ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	CDD
Device class	Class II
Decision date	Oct 27, 2017
Decision	Substantially Equivalent
Regulation	862.1810

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View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

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