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510(k) K822985

Device
EBV-M KIT
Applicant
LITTON BIONETICS
510(k) number
K822985
Product code
JRY  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-03
Date received
1982-10-12
Regulation
866.3235
Classification name
Antiserum, Fluorescent, Epstein-barr Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEMZeus Scientific, Inc.2005-04-29
K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.Stellar Bio Systems, Inc.1990-04-16
K891785BION EBV-G (VCA) TEST SYSTEMBion Ent., Ltd.1989-08-31
K884829EBV EARLY ANTIGEN (R+D)Hillcrest Biologicals1989-04-12
K822734EBV IGM TESTGull Laboratories, Inc.1982-12-09
K821849EBV-VCA ANTIBODY ASSAY KITBiotech Research Laboratories, Inc.1982-08-12
K811262EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTIZeus Scientific, Inc.1981-05-27
K780925EB-VCA, TEST, ANTIBODY, FLUORESCENTLitton Bionetics1978-06-22

Legacy Summary#

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FDA Review#

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