Product code ICF— Hematology

FDA has cleared 5 devices under product code ICF between 1979 and 1986, filed by 5 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.

• 19861 clearance
• 19842 clearances
• 19821 clearance
• 19791 clearance

• Volu Sol Medical Industries1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Intl. Remote Imaging Systems1 clearance
• E K Ind., Inc.1 clearance
• American Dade1 clearance

• K864531 — TISSUE GRAM STAINSigma Diagnostics, Inc.·1986-12-22
• K842537 — VON WILLEBRAND FACTOR ANTIGEN SCREENAmerican Dade·1984-10-01
• K842730 — GENTIAN VIOLETE K Ind., Inc.·1984-08-03
• K821503 — IRIS URINE STAINIntl. Remote Imaging Systems·1982-06-03
• K792495 — VOLU-SOL URINARY SEDIMENT STAINVolu Sol Medical Industries·1979-12-18