FDA 510(k) Applications for Medical Device Product Code "GMD"
(Antisera, Latex Agglutination, Cryptococcus Neoformans)

FDA 510(k) Number Applicant Device Name Decision Date
K102286 IMMUNO-MYCOLOGICS, INC. CRAG LATERAL FLOW ASSAY (CRAG LFA) 07/20/2011
K112422 IMMUNO-MYCOLOGICS, INC. CRAG LATERAL FLOW ASSAY (LFA) 03/28/2012


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