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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Iha, Toxoplasma Gondii
510(k) Number K851976
Device Name HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
Applicant
Si Sero-Immuno Diagnostics, Inc.
P.O. Box 1230
Tucker,  GA  30085
Applicant Contact IRVING G KAGAN
Correspondent
Si Sero-Immuno Diagnostics, Inc.
P.O. Box 1230
Tucker,  GA  30085
Correspondent Contact IRVING G KAGAN
Regulation Number866.3780
Classification Product Code
GMM  
Date Received05/07/1985
Decision Date 10/16/1985
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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