Product code LLA— Microbiology

FDA has cleared 4 devices under product code LLA between 1983 and 1993, filed by 3 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.

• 19931 clearance
• 19891 clearance
• 19851 clearance
• 19831 clearance

• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Biokit USA, Inc.1 clearance
• Ampcor, Inc.1 clearance

• K913467 — TOXOGENBiokit USA, Inc.·1993-01-11
• K890048 — QUIK-DOT TOXOPLASMOSISAmpcor, Inc.·1989-06-09
• K850768 — TOXOSCAN CARD TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic·1985-05-20
• K831930 — TOXO-SCREEN DA TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1983-09-26