Product code LYE— Immunology

FDA has cleared 2 devices under product code LYE, all in 1988, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Triton Biosciences, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K881259 — MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAILTriton Biosciences, Inc.·1988-10-12
• K864893 — ANTI-CYTOKERATIN MONOCLONAL ANTIBODYBd Becton Dickinson Vacutainer Systems Preanalytic·1988-07-07