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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Lactate Dehydrogenase Isoenzymes
510(k) Number K970477
Device Name HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
Applicant
Sebia
13805 Waterloo
Chelsea,  MI  48118
Applicant Contact BOREK JANIK, PH.D.
Correspondent
Sebia
13805 Waterloo
Chelsea,  MI  48118
Correspondent Contact BOREK JANIK, PH.D.
Regulation Number862.1445
Classification Product Code
CFE  
Date Received02/07/1997
Decision Date 03/10/1997
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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