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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K935288
Device Name SYNELISA CARDIOLIPIN 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 Number866.5660
Classification Product Code
MID  
Date Received11/03/1993
Decision Date 01/24/1994
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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