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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Histoplasma Capsulatum, All
510(k) Number K791393
Device Name HISTOPLASMA YEAST ANTI #CF10021X
Applicant
Immuno-Mycologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno-Mycologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3320
Classification Product Code
GMJ  
Date Received07/11/1979
Decision Date 08/16/1979
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
Recalls CDRH Recalls
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