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510(k) K142351

25-Hydroxy Vitamin Ds EIA by Immunodiagnostic Systems , Ltd. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2015
Date Received
August 22, 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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