Home / 510(k) Clearances / K133410

510(k) K133410

DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET by Diazyme Laboratories — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2014
Date Received
November 7, 2013
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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