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GSO — Antigens (Febrile), Agglutination, Brucella Spp. Class II

FDA Device Classification

Classification Details

Product Code
GSO
Device Class
Class II
Regulation Number
866.3085
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972394lee laboratoriesVISTA ANTIGEN BRUCELLA ABORTUSAugust 25, 1997
K972396lee laboratoriesVISTA ANTIGEN BRUCELLA MELITENSISAugust 25, 1997
K952139sa scientificSAS BRUCELLA SUIS ANTIGENJuly 18, 1995
K952140sa scientificSAS BRUCELLA MELTIENSIS ANTIGENJuly 17, 1995
K952131sa scientificSAS FEBRILE ANTIGEN SETJuly 17, 1995
K952135sa scientificSAS SALMONELLA H D ANTIGENJuly 17, 1995
K952147sa scientificSAS BRUCELLA ABORTUS ANTIGENJuly 17, 1995
K952137sa scientificSAS SALMONELLA H A ANTIGENJuly 17, 1995
K952136sa scientificSAS SALMONELLA H B ANTIGENJuly 17, 1995
K885112investigacion farmaceutica s.a. de c.vBRUCELLA IFA*August 15, 1989
K822663oxoid u.s.aFEBRILE ANTIGEN KITSeptember 21, 1982
K791449volu sol medical industriesAGGLUTINOTEST-BRUCELLASeptember 24, 1979