Home / 510(k) Clearances / K153375

510(k) K153375

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls by Abbott Laboratories — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2016
Date Received
November 23, 2015
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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