Product code ICL— Hematology

FDA has cleared 4 devices under product code ICL between 1977 and 1989, 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.

• 19891 clearance
• 19841 clearance
• 19791 clearance
• 19771 clearance

• Laboratory Products, Inc.1 clearance
• Harleco1 clearance
• E K Ind., Inc.1 clearance
• Alpha-Tec Systems, Inc.1 clearance

• K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45Alpha-Tec Systems, Inc.·1989-01-24
• K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSENE K Ind., Inc.·1984-09-11
• K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSELaboratory Products, Inc.·1979-12-18
• K771390 — HISTOCHEMICAL AFB DEMONSTRATIONHarleco·1977-08-22