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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 K900604
Device Name DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
Applicant
Biovir Laboratories, Inc.
685 Stone Rd., Unit 6
Benicia,  CA  94510
Applicant Contact RIGGS, PHD
Correspondent
Biovir Laboratories, Inc.
685 Stone Rd., Unit 6
Benicia,  CA  94510
Correspondent Contact RIGGS, PHD
Regulation Number866.3220
Classification Product Code
KHW  
Date Received02/08/1990
Decision Date 07/26/1990
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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