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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K982539
Device Name HDLC PRECIPITATING REAGENT
Applicant
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Applicant Contact C. C ALLAIN
Correspondent
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Correspondent Contact C. C ALLAIN
Regulation Number862.1475
Classification Product Code
LBS  
Date Received07/21/1998
Decision Date 09/15/1998
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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