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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
510(k) Number K842660
Device Name ANTI-SCHISTOSOMA SPECIES KIT
Applicant
Amico Lab, Inc.
TN  37209
Applicant Contact ABDALLAH M ISA
Correspondent
Amico Lab, Inc.
TN  37209
Correspondent Contact ABDALLAH M ISA
Regulation Number866.3600
Classification Product Code
GNH  
Date Received07/10/1984
Decision Date 10/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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