Name: Predicase
Price: 199 USD

K-number	K160757
Device name	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
Applicant	Axis-Shield Diagnostics Limited
Product code	CDD
Device class	Class II
Decision date	Jul 26, 2016
Decision	Substantially Equivalent
Regulation	862.1810

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

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