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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Lactate Dehydrogenase Isoenzymes
510(k) Number K020467
Device Name SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PATRICIA FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PATRICIA FRANKS
Regulation Number862.1445
Classification Product Code
CFE  
Date Received02/12/2002
Decision Date 03/29/2002
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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