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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
Model SRY 101
Device Name ALPHA CRYPTOCOCCAL ANTIGEN EIA
Original Applicant
IMMUNO-MYCOLOGICS, INC.
2700 technology place
norman,  OK  73071
Original Contact sean k bauman
Regulation Number866.3165
Classification Product Code
MDU  
Date Received03/29/2012
Decision Date 12/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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