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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
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