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

FDA 510(k) Number Applicant Device Name Decision Date
K820895 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI 05/03/1982
K860279 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT 05/13/1986
K904036 BAXTER HEALTHCARE CORP. BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN 10/16/1990
K894002 BAXTER HEALTHCARE CORP. CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY 08/10/1989
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
K934798 DIAGNOSTIC PRODUCTS CORP. PATHODX CYTOMEGALOVIRUS 03/25/1994
K912592 GULL LABORATORIES, INC. CMV-EA MAB TEST 12/04/1991
K822606 IMMULOK, INC. CYTOMEGALOVIRUS ANTOBODY IGG 11/01/1982
K893467 IMMUNO CONCEPTS, INC. CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) 07/14/1989
K893468 IMMUNO CONCEPTS, INC. CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) 07/14/1989
K921616 INCSTAR CORP. CMV-VUE(TM) CMV ANTIGEN DETECTION KIT 08/11/1992
K951821 LIGHT DIAGNOSTICS CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY 06/07/1996
K843138 MICROBIOLOGICAL RESEARCH CORP. CMV TEST 01/29/1985
K983762 ORGANON TEKNIKA CORP. NUCLISENS CMV PP67 09/15/1999
K905257 PB DIAGNOSTIC SYSTEMS, INC. OPUS CMV TEST SYSTEM 04/17/1991


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