FDA 510(k) Applications for Medical Device Product Code "LIN"
(Antisera, Conjugated Fluorescent, Cytomegalovirus)

FDA 510(k) Number Applicant Device Name Decision Date
K951550 BIOTEST DIAGNOSTICS CORP. CMV BRITE ANTIGENEMIA TEST KIT 01/30/1996
K991650 BIOTEST DIAGNOSTICS CORP. CMV BRITE TURBO KIT 07/12/1999
K081164 DIAGNOSTIC HYBRIDS, INC. D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT 06/13/2008
K951821 LIGHT DIAGNOSTICS CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY 06/07/1996
K983762 ORGANON TEKNIKA CORP. NUCLISENS CMV PP67 09/15/1999


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