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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoresis Instrumentation
510(k) Number K933123
Device Name SYNELISA TG ANTIBODIES/TPO ANTIBODIES
Applicant
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Applicant Contact GOTTFRIED KELLERMANN
Correspondent
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Correspondent Contact GOTTFRIED KELLERMANN
Regulation Number866.4500
Classification Product Code
JZS  
Date Received06/28/1993
Decision Date 08/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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