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510(k) K141114

BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D by Bio-Rad Laboratories — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2015
Date Received
April 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Vitamin D
Device Class
Class II
Regulation Number
862.1825
Review Panel
CH
Submission Type

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