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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Lipoproteins
510(k) Number K013466
Device Name SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
Applicant
HELENA LABORATORIES
P.O. BOX 752
1530 LINDBERGH DRIVE
BEAUMONT,  TX  77704
Applicant Contact PATRICIA FRANKS
Correspondent
HELENA LABORATORIES
P.O. BOX 752
1530 LINDBERGH DRIVE
BEAUMONT,  TX  77704
Correspondent Contact PATRICIA FRANKS
Regulation Number862.1475
Classification Product Code
JHO  
Date Received10/18/2001
Decision Date 12/21/2001
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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