K-number	K112443
Device name	ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	CDD
Device class	Class II
Decision date	Dec 19, 2011
Decision	Substantially Equivalent
Regulation	862.1810

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ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

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