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510(k) K072536

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST by Esa Biosciences, Inc. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2008
Date Received
September 7, 2007
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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