FDA.reportPublic FDA data

510(k) K934798

Device
Pathodx Cytomegalovirus
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K934798
Product code
LIN
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-25
Date received
1993-10-07
Regulation
866.3175
Classification name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DEBORAH WILMERS
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITDiagnostic Hybrids, Inc.2008-06-13
K983762NUCLISENS CMV PP67Organon Teknika Corp.1999-09-15
K991650CMV BRITE TURBO KITBiotest Diagnostics Corp.1999-07-12
K951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight Diagnostics1996-06-07
K951550CMV BRITE ANTIGENEMIA TEST KITBiotest Diagnostics Corp.1996-01-30
K921616CMV-VUE(TM) CMV ANTIGEN DETECTION KITIncstar Corp.1992-08-11
K912592CMV-EA MAB TESTGull Laboratories, Inc.1991-12-04
K905257OPUS CMV TEST SYSTEMPb Diagnostic Systems, Inc.1991-04-17
K904036BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGENBaxter Healthcare Corp1990-10-16
K894002CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODYBaxter Healthcare Corp1989-08-10
K893468CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)Immuno Concepts, Inc.1989-07-14
K893467CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)Immuno Concepts, Inc.1989-07-14
K860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITBartels Immunodiagnostic Supplies, Inc.1986-05-13
K843138CMV TESTMicrobiological Research Corp.1985-01-29
K822606CYTOMEGALOVIRUS ANTOBODY IGGImmulok, Inc.1982-11-01