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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K011113
Device Name HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
Applicant
Sebia
13805 Waterloo
Chelsea,  MI  48118
Applicant Contact BOREK JANIK
Correspondent
Sebia
13805 Waterloo
Chelsea,  MI  48118
Correspondent Contact BOREK JANIK
Regulation Number862.1050
Classification Product Code
CIN  
Date Received04/11/2001
Decision Date 06/13/2001
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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