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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 K080973
Device Name CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
Applicant
Cliniqa Corporation
774 N. Twin Oaks Valley Rd.
San Marcos,  CA  92069
Applicant Contact CAROL RUGGIERO
Correspondent
Cliniqa Corporation
774 N. Twin Oaks Valley Rd.
San Marcos,  CA  92069
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/04/2008
Decision Date 06/02/2008
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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