FDA.reportPublic FDA data

510(k) K913467

Device
TOXOGEN
Applicant
BIOKIT USA, INC.
510(k) number
K913467
Product code
LLA  
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-11
Date received
1991-08-05
Regulation
866.3780
Classification name
Direct Agglutination Test, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ODRIOZOLA
Address
Can Male Llissa D'Amunt Barcelona ES 08186 08186

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
K890048QUIK-DOT TOXOPLASMOSISAmpcor, Inc.1989-06-09
K850768TOXOSCAN CARD TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic1985-05-20
K831930TOXO-SCREEN DA TESTBd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases