K-number	K180577
Device name	BioPlex 2200 25-OH Vitamin D Kit
Applicant	Bio-Rad Laboratories
Product code	MRG
Device class	Class II
Decision date	Jun 22, 2018
Decision	Substantially Equivalent
Regulation	862.1825

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View the full FDA submission: accessdata.fda.gov

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BioPlex 2200 25-OH Vitamin D Kit

Everything you need for a 510(k) submission. Nothing you don't.