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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic, protein fractionation
510(k) Number K964453
Device Name REP 3 FLUR SPE-60 KIT
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 Number862.1630
Classification Product Code
CEF  
Date Received11/06/1996
Decision Date 12/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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