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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 K852237
Device Name LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
Applicant
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Applicant Contact MONICA S KRIEGER
Correspondent
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Correspondent Contact MONICA S KRIEGER
Regulation Number866.3300
Classification Product Code
LHL  
Date Received05/22/1985
Decision Date 08/22/1985
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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