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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K120626
Device Name EON CALCIUM REGENT
Applicant
Vital Diagnostics (Manufacturing) Ptyltd
189-199 Browns Rd.
Noble Park,  AU 3174
Applicant Contact MELITA LAMBIRIS
Correspondent
Vital Diagnostics (Manufacturing) Ptyltd
189-199 Browns Rd.
Noble Park,  AU 3174
Correspondent Contact MELITA LAMBIRIS
Regulation Number862.1145
Classification Product Code
CJY  
Date Received03/01/2012
Decision Date 08/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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