Product code KFC— Hematology

FDA has cleared 7 devices under product code KFC between 1977 and 1988, filed by 6 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.

• 19881 clearance
• 19844 clearances
• 19831 clearance
• 19771 clearance

• E K Ind., Inc.2 clearances
• Sigma Diagnostics, Inc.1 clearance
• Reagent Laboratory, Inc.1 clearance
• Flaitron Laboratories, Inc.1 clearance
• Difco Laboratories, Inc.1 clearance
• Corning Medical & Scientific1 clearance

• K875310 — RETICULOCYTE STAINSigma Diagnostics, Inc.·1988-02-09
• K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAINDifco Laboratories, Inc.·1984-10-30
• K842785 — STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.·1984-09-11
• K842926 — METHYLENE BLUE STAIN, LOEFFLERE K Ind., Inc.·1984-09-11
• K842743 — NEW METHYLENE BLUE NE K Ind., Inc.·1984-08-12
• K831502 — NEPHROLYTEFlaitron Laboratories, Inc.·1983-07-18
• K770792 — TUBE, STAIN, RETICULOCYTE, LARCCorning Medical & Scientific·1977-07-05