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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, Candida Albicans
510(k) Number K812186
Device Name CANDIDA IMMUNODIFFUSION SYSTEM
Applicant
American Scientific Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Scientific Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3165
Classification Product Code
LHK  
Date Received08/03/1981
Decision Date 08/25/1981
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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