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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Positive Control, Blastomyces Dermatitidis
510(k) Number K880029
Device Name EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
Applicant
Immuno-Mycologics, Inc.
P.O. Box 1151
Norman,  OK  73070
Applicant Contact BAUMAN, PHD
Correspondent
Immuno-Mycologics, Inc.
P.O. Box 1151
Norman,  OK  73070
Correspondent Contact BAUMAN, PHD
Regulation Number866.3060
Classification Product Code
KFH  
Date Received01/05/1988
Decision Date 02/24/1988
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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