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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K041898
Device Name CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
Applicant
Cliniqa Corporation
1432 S. Mission Rd.
Fallbrook,  CA  92028
Applicant Contact CAROL RUGGIERO
Correspondent
Cliniqa Corporation
1432 S. Mission Rd.
Fallbrook,  CA  92028
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/14/2004
Decision Date 08/16/2004
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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