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510(k) K772243

Device
TOXO TEST
Applicant
GULL LABORATORIES, INC.
510(k) number
K772243
Product code
GLZ  
Decision
Substantially Equivalent (SESE)
Decision date
1977-12-22
Date received
1977-12-08
Regulation
866.3780
Classification name
Antigens, If, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Toxicology
Device class
2
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 GLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924882TOXOPLASMA IGM IFA TEST SYSTEMZeus Scientific, Inc.1993-03-23
K880007TOXO IGM TESTGull Laboratories, Inc.1988-03-17
K850591FIAX TOXO-M ANTIBODIES TEST KITIntl. Diagnostic Technology1985-04-30
K844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIApple Diagnostic Products1985-01-07
K842664ANTI-TOXOPLASMA GONDII KITAmico Lab, Inc.1984-08-28
K832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIBionetic Laboratory Products1983-11-14
K830869POLYCHACO INDIRECT IMMUNOFLUORESCENCEParasitic Disease Consultants1983-08-11
K811562TOXOPLASMOSIS TEST KITImmuno-Diagnostic Products, Inc.1981-07-16
K803134TOXOPLASMA GONDII SEROLOGICAL REAGENTSMicrobiological Research Corp.1981-01-29
K801720TOXO BIO-BEAD TITRATION KITLitton Bionetics1980-09-16
K791618TORCH BIO-BEAD SCREEN KITLitton Bionetics1979-11-13
K791611TOXO BIO-BEAD SCREEN KITLitton Bionetics1979-11-13
K791571TOXOPLASMA ANTIBODY TEST SYSTEMZeus Scientific, Inc.1979-09-24
K790464FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBOIntl. Diagnostic Technology1979-06-13
K790360QUANTAZYME TOXOPLASMABio-Rad1979-05-22

Legacy Summary#

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FDA Review#

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