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510(k) K123660

25-OH VITAMIN D ELISA by Euroimmun US — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2013
Date Received
November 28, 2012
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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