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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 K882368
Device Name REP HDL ELECTROPHORESIS METHOD
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Applicant Contact ERIC PETERSEN
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Correspondent Contact ERIC PETERSEN
Regulation Number862.1475
Classification Product Code
LBT  
Date Received06/08/1988
Decision Date 08/08/1988
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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