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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 K083554
Device Name CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
Applicant
Cliniqa Corporation
288 Distribution St.
San Marcos,  CA  92078
Applicant Contact DAWN GAST
Correspondent
Cliniqa Corporation
288 Distribution St.
San Marcos,  CA  92078
Correspondent Contact DAWN GAST
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/01/2008
Decision Date 04/21/2009
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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