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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 K022455
Device Name SPIFE LD-12 KIT, MODEL 3338
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 Received07/26/2002
Decision Date 10/01/2002
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
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