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510(k) K910872

Device
EBV IGG ELISA TEST
Applicant
GULL LABORATORIES, INC.
510(k) number
K910872
Product code
MCD  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-12
Date received
1991-03-01
Regulation
866.3235
Classification name
Antigen, Ebv, Capsid
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRED W RACHFORD
Address
1011 E. 4800 S. Salt Lake City UT US 84117 84117

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984126THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.1999-01-11
K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTVirion (U.S.), Inc.1994-06-13
K925689MERIDIAN EBV-IGG TEST KITFuller Laboratories, Inc.1993-10-12
K924091EBV-VCA IGG ELISA TEST SYSTEMZeus Scientific, Inc.1993-01-11
K920412MODIFIED ORTHO EBV VCA-IGG ELISAOrtho Diagnostic Systems, Inc.1992-06-22
K911570EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.1991-06-10
K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.1991-06-10

Legacy Summary#

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FDA Review#

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