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510(k) K123131

ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI by Tosoh Bioscience, Inc. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2013
Date Received
October 4, 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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