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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 K031921
Device Name LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
Applicant
CLINIQA CORPORATION
1432-B SOUTH MISSION RD.
FALLBROOK,  CA  92028
Applicant Contact CAROL RUGGIERO
Correspondent
CLINIQA CORPORATION
1432-B SOUTH MISSION RD.
FALLBROOK,  CA  92028
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/23/2003
Decision Date 08/25/2003
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
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