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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 K930317
Device Name REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
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 Received01/22/1993
Decision Date 08/03/1993
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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