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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K120202
Device Name EON CHOLESTEROL REAGENT
Applicant
VITAL DIAGNOSTICS PTY. LTD
189 - 199 BROWNS ROAD
NOBLE PARK, VICTORIA,  AU 3174
Applicant Contact MELITA LAMBIRIS
Correspondent
VITAL DIAGNOSTICS PTY. LTD
189 - 199 BROWNS ROAD
NOBLE PARK, VICTORIA,  AU 3174
Correspondent Contact MELITA LAMBIRIS
Regulation Number862.1175
Classification Product Code
CHH  
Date Received01/23/2012
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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