FDA 510(k) Applications for Medical Device Product Code "OMG"
(Antisera, Fluorescent, Human Metapneumovirus)

FDA 510(k) Number Applicant Device Name Decision Date
K090073 DIAGNOSTIC HYBRIDS, INC. D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT 03/06/2009
K093233 DIAGNOSTIC HYBRIDS, INC. D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT 12/04/2009
K091171 DIAGNOSTIC HYBRIDS, INC. D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT 09/11/2009
K093815 MILLIPORE CORPORATION LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 03/12/2010


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