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510(k) K864981

Device
TOXOPLASMA GONDII
Applicant
VIRION (U.S.), INC.
510(k) number
K864981
Product code
GMN  
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-30
Date received
1986-12-22
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#

Contact
EDWIN H LENNETTE,MD
Address
4 Upperfield Rd. Morristown NJ US 07960 07960

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
K791456AGGLUTINOTEST-TOXOPLASMOSISVolu Sol Medical Industries1979-09-24

Legacy Summary#

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FDA Review#

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