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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K060322
Device Name CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
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 Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJY  
Date Received02/09/2006
Decision Date 03/21/2006
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
Recalls CDRH Recalls
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