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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antigen, elisa, cryptococcus
510(k) Number K120946
Device Name ALPHA CRYPTOCOCCAL ANTIGEN EIA
Original Applicant
IMMUNO-MYCOLOGICS, INC.
116 s crawford ave
norman,  OK  73069
Original Contact sean k bauman
Regulation Number866.3165
Classification Product Code
MDU  
Date Received03/29/2012
Decision Date 12/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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