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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K033910
Device Name OLYMPUS URINE CALIBRATOR
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 Number862.1150
Classification Product Code
JIX  
Date Received12/17/2003
Decision Date 01/30/2004
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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