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510(k) K120626

EON CALCIUM REGENT by Vital Diagnostics (Manufacturing) Ptyltd — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2012
Date Received
March 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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