Product code DFI— Immunology

FDA has cleared 4 devices under product code DFI between 1983 and 1985, 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.

• 19851 clearance
• 19842 clearances
• 19831 clearance

• Somas Medical Industries, Inc.1 clearance
• Isolab, Inc.1 clearance
• Intl. Diagnostic Technology1 clearance
• Canyon Diagnostics, Inc.1 clearance

• K854190 — CANTROL SPINAL FLUID CONTROLCanyon Diagnostics, Inc.·1985-11-25
• K843122 — RESOLVE-CSFIsolab, Inc.·1984-11-30
• K840974 — SOMAS HUMAN SPINAL FLUID CONTROLSomas Medical Industries, Inc.·1984-04-05
• K832821 — FIAX IGG TESTIntl. Diagnostic Technology·1983-10-14