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510(k) K894261

Device
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
Applicant
MICROBIX BIOSYSTEMS, INC.
510(k) number
K894261
Product code
GMN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-16
Date received
1989-06-21
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
JANIS FREESTONE
Address
Darts Mill Flemington NJ US 08822 08822

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
K864981TOXOPLASMA GONDIIVirion (U.S.), Inc.1987-10-30
K791456AGGLUTINOTEST-TOXOPLASMOSISVolu Sol Medical Industries1979-09-24

Legacy Summary#

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FDA Review#

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