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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 K030566
Device Name LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
Applicant
CLINIQA CORPORATION
1432 SOUTH MISSION RD.
FALLBROOK,  CA  92028
Applicant Contact CAROL RUGGIERO
Correspondent
CLINIQA CORPORATION
1432 SOUTH MISSION RD.
FALLBROOK,  CA  92028
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/24/2003
Decision Date 03/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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