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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antisera, latex agglutination, cryptococcus neoformans
510(k) Number K112422
FOIA Releasable 510(k) K112422
Device Name CRAG LATERAL FLOW ASSAY (LFA)
Applicant
IMMUNO-MYCOLOGICS, INC.
2700 TECHNOLOGY PLACE
NORMAN,  OK  73071
Applicant Contact SEAN K BAUMAN
Correspondent
IMMUNO-MYCOLOGICS, INC.
2700 TECHNOLOGY PLACE
NORMAN,  OK  73071
Correspondent Contact SEAN K BAUMAN
Regulation Number866.3165
Classification Product Code
GMD  
Date Received08/23/2011
Decision Date 03/28/2012
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
Recalls CDRH Recalls
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