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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K832896
Device Name LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
Applicant
Biodan Medical Systems, Ltd.
Kiryat Weizmann
P.O. Box 2012
Rehovot, Israel, 
Correspondent
Biodan Medical Systems, Ltd.
Kiryat Weizmann
P.O. Box 2012
Rehovot, Israel, 
Regulation Number866.3300
Classification Product Code
LHL  
Date Received08/23/1983
Decision Date 10/14/1983
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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