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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
510(k) Number K874849
Device Name PROSPECT/GIARDIA
Applicant
Alexon Biomedical, Inc.
868 Baker Court
Glen Ellyn,  IL  60137
Applicant Contact COLES, PH.D.
Correspondent
Alexon Biomedical, Inc.
868 Baker Court
Glen Ellyn,  IL  60137
Correspondent Contact COLES, PH.D.
Regulation Number866.3220
Classification Product Code
KHW  
Date Received11/25/1987
Decision Date 01/05/1988
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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