FDA 510(k) Applications for Medical Device Product Code "NZB"
(Quality Control Material, Genetics, Dna)

FDA 510(k) Number Applicant Device Name Decision Date
K063224 GENTRIS CORPORATION GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL 12/22/2006
K093737 INSTRUMENTATION LABORATORY CO. HEMOSIL F11 & FV DNA CONTROL 05/04/2010
DEN060007 MAINE MOLECULAR QUALITY CONTROLS, INC. INTROL CF PANEL I CONTROL 10/12/2006
K083171 MAINE MOLECULAR QUALITY CONTROLS, INC. INTROL CF PANEL I CONTROL, MODEL: G106 12/16/2008


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