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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 K951536
Device Name HYDRAGEL PROTEIN(E) KIT
Applicant
Sebia
13805 Waterloo
Chelsea,  MI  48118
Applicant Contact BOREK JANIK
Correspondent
Sebia
13805 Waterloo
Chelsea,  MI  48118
Correspondent Contact BOREK JANIK
Regulation Number862.1630
Classification Product Code
CEF  
Date Received04/03/1995
Decision Date 06/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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