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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K904035
Device Name REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number862.1475
Classification Product Code
LBT  
Date Received08/31/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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