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510(k) K861363

Device
Enzygnost Anti-cmv Igm Test
Applicant
BEHRING DIAGNOSTICS, INC.
510(k) number
K861363
Product code
LKQ
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-21
Date received
1986-04-10
Regulation
866.3175
Classification name
Antibody Igm,If, Cytomegalovirus Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN E HUGHES
Address
10933 No Torrey Pines Rd. La Jolla CA US 92037 92037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,Siemens Healthcare Diagnostics2010-05-13
K972884ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.1997-08-22
K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.1994-08-02
K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.1993-04-08
K914789ELISA CMV IGMSclavo, Inc.1992-03-04
K913080OPUS(R) ANTI CMV-MPb Diagnostics, Inc.1991-10-28
K900743CMV-IGM IFA TEST SYSTEMZeus Scientific, Inc.1990-04-26
K893465CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)Immuno Concepts, Inc.1989-07-25
K893466CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)Immuno Concepts, Inc.1989-07-14
K872881ABBOTT CMV-M EIA KITAbbott Laboratories1988-05-13
K872942IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530Clinical Sciences, Inc.1988-01-11
K871832CMV IGM MICROASSAYDiamedix Corp.1987-08-07
K863798FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIESWhittaker Bioproducts, Inc.1987-04-14
K860450THE CMV-IGM TESTMicrobiological Research Corp.1986-05-13
K853889CORDIA CMV-MCordis Corp.1986-04-21