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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K111063
Device Name VITAL SERUM CONTROLS
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
189-190 BROWNS ROAD
NOBLE PARK VICTORIA,  AT 3174
Applicant Contact MELITA LAMBIRIS
Correspondent
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
189-190 BROWNS ROAD
NOBLE PARK VICTORIA,  AT 3174
Correspondent Contact MELITA LAMBIRIS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/18/2011
Decision Date 06/28/2011
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
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