Product code LGO— Hematology

FDA has cleared 5 devices under product code LGO between 1977 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19901 clearance
• 19881 clearance
• 19791 clearance
• 19772 clearances

• Hyland Therapeutic Div., Travenol Laboratories2 clearances
• Molecular Biosystems, Inc.1 clearance
• Kallestad Diag, A Div. of Erbamont, Inc.1 clearance
• Calbiochem-Behring Corp.1 clearance

• K894947 — PLATELIA TOXO IGG KITKallestad Diag, A Div. of Erbamont, Inc.·1990-03-23
• K874544 — SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KITMolecular Biosystems, Inc.·1988-08-12
• K791118 — HLA CONTROL SERACalbiochem-Behring Corp.·1979-08-03
• K761008 — LYMPHOCYTE TYPING, NEGATIVE CONTROLHyland Therapeutic Div., Travenol Laboratories·1977-04-06
• K761009 — LYMPHOCYTE TYPING, POSITIVE CONTROLHyland Therapeutic Div., Travenol Laboratories·1977-04-06