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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 K913807
Device Name REP(R) SPE TEMPLATE 30, 16, & 8
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 Received08/26/1991
Decision Date 11/27/1991
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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