Product code GSO— Microbiology

FDA has cleared 12 devices under product code GSO between 1979 and 1997, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19972 clearances
• 19957 clearances
• 19891 clearance
• 19821 clearance
• 19791 clearance

• Sa Scientific, Inc.7 clearances
• Lee Laboratories, Inc.2 clearances
• Volu Sol Medical Industries1 clearance
• Oxoid U.S.A., Inc.1 clearance
• Investigacion Farmaceutica S.A. DE C.V.1 clearance

• K972394 — VISTA ANTIGEN BRUCELLA ABORTUSLee Laboratories, Inc.·1997-08-25
• K972396 — VISTA ANTIGEN BRUCELLA MELITENSISLee Laboratories, Inc.·1997-08-25
• K952139 — SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.·1995-07-18
• K952131 — SAS FEBRILE ANTIGEN SETSa Scientific, Inc.·1995-07-17
• K952135 — SAS SALMONELLA H D ANTIGENSa Scientific, Inc.·1995-07-17
• K952136 — SAS SALMONELLA H B ANTIGENSa Scientific, Inc.·1995-07-17
• K952137 — SAS SALMONELLA H A ANTIGENSa Scientific, Inc.·1995-07-17
• K952140 — SAS BRUCELLA MELTIENSIS ANTIGENSa Scientific, Inc.·1995-07-17
• K952147 — SAS BRUCELLA ABORTUS ANTIGENSa Scientific, Inc.·1995-07-17
• K885112 — BRUCELLA IFA*Investigacion Farmaceutica S.A. DE C.V.·1989-08-15
• K822663 — FEBRILE ANTIGEN KITOxoid U.S.A., Inc.·1982-09-21
• K791449 — AGGLUTINOTEST-BRUCELLAVolu Sol Medical Industries·1979-09-24