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510(k) K831930

Device
TOXO-SCREEN DA TEST
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K831930
Product code
LLA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-26
Date received
1983-06-15
Regulation
866.3780
Classification name
Direct Agglutination Test, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913467TOXOGENBiokit USA, Inc.1993-01-11
K890048QUIK-DOT TOXOPLASMOSISAmpcor, Inc.1989-06-09
K850768TOXOSCAN CARD TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic1985-05-20

Legacy Summary#

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FDA Review#

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