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510(k) K791456

Device
AGGLUTINOTEST-TOXOPLASMOSIS
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K791456
Product code
GMN  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-24
Date received
1979-08-06
Regulation
866.3780
Classification name
Antigens, Cf, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.1989-10-16
K864981TOXOPLASMA GONDIIVirion (U.S.), Inc.1987-10-30

Legacy Summary#

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FDA Review#

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