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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Rnp Antibody, Antigen And Control
510(k) Number K930142
Device Name SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
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 Number866.5100
Classification Product Code
LKO  
Date Received01/12/1993
Decision Date 05/11/1993
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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