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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 K012855
Device Name LIQUISPX LIQUID LIPID CONTROL
Applicant
CLINICAL CONTROLS DIVISION
12038 CENTRALIA AVE.
UNIT C
HAWAIIAN GARDENS,  CA  90716
Applicant Contact JAMES F GODFREY
Correspondent
CLINICAL CONTROLS DIVISION
12038 CENTRALIA AVE.
UNIT C
HAWAIIAN GARDENS,  CA  90716
Correspondent Contact JAMES F GODFREY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/24/2001
Decision Date 08/30/2001
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
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