Product code LEA— Pathology

FDA has cleared 4 devices under product code LEA between 1976 and 1987, filed by 3 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.

• 19871 clearance
• 19771 clearance
• 19762 clearances

• Lerner Laboratories, Inc.2 clearances
• Surgipath Medical Industries, Inc.1 clearance
• Devetec, Inc.1 clearance

• K873594 — TIF FECAL TESTDevetec, Inc.·1987-09-29
• K770592 — CYTOLOGY FIXATIVESurgipath Medical Industries, Inc.·1977-05-20
• K761000 — PAP-TRAY I (CATALOG #C600-1)Lerner Laboratories, Inc.·1976-12-06
• K761001 — PAP-TRAY II (CATALOG #C600-2)Lerner Laboratories, Inc.·1976-12-06