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510(k) K972394

Device
VISTA ANTIGEN BRUCELLA ABORTUS
Applicant
LEE LABORATORIES, INC.
510(k) number
K972394
Product code
GSO  
Decision
Substantially Equivalent (SESE)
Decision date
1997-08-25
Date received
1997-06-26
Regulation
866.3085
Classification name
Antigens (febrile), Agglutination, Brucella Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBIN C HART
Address
1475 Hwy. 78, SW Grayson GA US 30221 30221

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GSO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972396VISTA ANTIGEN BRUCELLA MELITENSISLee Laboratories, Inc.1997-08-25
K952139SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.1995-07-18
K952131SAS FEBRILE ANTIGEN SETSa Scientific, Inc.1995-07-17
K952135SAS SALMONELLA H D ANTIGENSa Scientific, Inc.1995-07-17
K952136SAS SALMONELLA H B ANTIGENSa Scientific, Inc.1995-07-17
K952137SAS SALMONELLA H A ANTIGENSa Scientific, Inc.1995-07-17
K952140SAS BRUCELLA MELTIENSIS ANTIGENSa Scientific, Inc.1995-07-17
K952147SAS BRUCELLA ABORTUS ANTIGENSa Scientific, Inc.1995-07-17
K885112BRUCELLA IFA*Investigacion Farmaceutica S.A. DE C.V.1989-08-15
K822663FEBRILE ANTIGEN KITOxoid U.S.A., Inc.1982-09-21
K791449AGGLUTINOTEST-BRUCELLAVolu Sol Medical Industries1979-09-24

Legacy Summary#

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FDA Review#

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