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510(k) K172992

Diazyme EZ Vitamin D Assay by Diazyme Laboratories — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2018
Date Received
September 27, 2017
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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