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510(k) K890048

Device
QUIK-DOT TOXOPLASMOSIS
Applicant
AMPCOR, INC.
510(k) number
K890048
Product code
LLA  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-09
Date received
1989-01-06
Regulation
866.3780
Classification name
Direct Agglutination Test, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND GOULD
Address
510 Heron Dr., Bldg. 306 P.O. Box 521 Bridgeport NJ US 08014 08014

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
K850768TOXOSCAN CARD TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic1985-05-20
K831930TOXO-SCREEN DA TESTBd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26

Legacy Summary#

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FDA Review#

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