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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Direct Agglutination Test, Toxoplasma Gondii
510(k) Number K913467
Device Name TOXOGEN
Applicant
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact ODRIOZOLA
Correspondent
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact ODRIOZOLA
Regulation Number866.3780
Classification Product Code
LLA  
Date Received08/05/1991
Decision Date 01/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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