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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 K951187
Device Name VARELISA CARDIOLIPIN ABS SCREEN
Applicant
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Correspondent
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Regulation Number866.5660
Classification Product Code
MID  
Date Received03/16/1995
Decision Date 10/02/1995
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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