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510(k) K920412

Device
MODIFIED ORTHO EBV VCA-IGG ELISA
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
510(k) number
K920412
Product code
MCD  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-22
Date received
1992-01-31
Regulation
866.3235
Classification name
Antigen, Ebv, Capsid
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KIN W GRAY
Address
1125 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K910872EBV IGG ELISA TESTGull Laboratories, Inc.1991-04-12

Legacy Summary#

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FDA Review#

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