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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 K102286
Device Name CRAG LATERAL FLOW ASSAY (CRAG LFA)
Applicant
Immuno-Mycologics, Inc.
2700 Technology Pl.
Norman,  OK  73071
Applicant Contact SEAN BAUMAN
Correspondent
Immuno-Mycologics, Inc.
2700 Technology Pl.
Norman,  OK  73071
Correspondent Contact SEAN BAUMAN
Regulation Number866.3165
Classification Product Code
GMD  
Date Received08/12/2010
Decision Date 07/20/2011
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
Predetermined Change
Control Plan Authorized		 No
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