Product code LIZ— Hematology

FDA has cleared 7 devices under product code LIZ between 1982 and 1992, filed by 6 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.

• 19921 clearance
• 19861 clearance
• 19851 clearance
• 19842 clearances
• 19831 clearance
• 19821 clearance

• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Technicon Instruments Corp.1 clearance
• Ortho Diagnostic Systems, Inc.1 clearance
• Gen Trak, Inc.1 clearance
• Control Diagnostics1 clearance
• Bio-Rad1 clearance

• K914847 — CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.·1992-06-19
• K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.·1986-09-08
• K843062 — TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems Preanalytic·1985-04-03
• K842218 — ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems Preanalytic·1984-12-27
• K833929 — WHITE BLOOD CELLS HUMAN TAND BControl Diagnostics·1984-02-03
• K831053 — QUANTIGEN T & B CELL ASSAYBio-Rad·1983-08-08
• K820643 — ORTHO SPECTRUM III & ORTHO-MUNE OKOrtho Diagnostic Systems, Inc.·1982-07-14