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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, Systemic Lupus Erythematosus
510(k) Number K930421
Device Name ELIAS DSDNA ABS
Applicant
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Applicant Contact GOTTFRIED KELLERMAN
Correspondent
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Correspondent Contact GOTTFRIED KELLERMAN
Regulation Number866.5820
Classification Product Code
DHC  
Date Received01/26/1993
Decision Date 03/10/1993
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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