Product code LCE— Clinical Toxicology

FDA has cleared 6 devices under product code LCE between 1982 and 1983, filed by 5 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.

• 19832 clearances
• 19824 clearances

• Syva Co.2 clearances
• Miles Laboratories, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• American Diagnostic Corp.1 clearance
• Abbott Laboratories1 clearance

• K833715 — EMIT NETILMICIN ASSAYSyva Co.·1983-12-27
• K832088 — AMES TDA NETILMICIN TEST & SERUMMiles Laboratories, Inc.·1983-10-28
• K822941 — NETILMICIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.·1982-10-26
• K821698 — TDX NETILMICINAbbott Laboratories·1982-06-22
• K821399 — MACRO-VUE CARD TEST, NETILMICINBd Becton Dickinson Vacutainer Systems Preanalytic·1982-05-28
• K820324 — EMIT AND NETILMICIN ASSAYSyva Co.·1982-02-23